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GUDID

1. below the parent trade item next lower level Issuing Additional Attribute additionalTradeltemlde Code This code will be used to additionalTradel tem Agency KeyDataT ntificationTypeCode cross reference the Vendors I dentificationType ypes internal trade item number to the GTIN in a one to one relationship Secondary DI GSlldenti Attribute additionalTradeltemlde AdditionalTradelte Alternative means to the additionalTradeltem Number ficationCo ntification ml dentification Global Trade Item Number to I dentificationValue mponents identify a trade item Package DI Package DI GS1ldenti Attribute gtin GTIN Global Trade Item Number globalTradel temNu Number ficationCo GTIN the GS1 key used for mber mponents the identification of trade use hierarchy to items obtain parent child information N A Coreltem Attribute quantityOfChildren nonNegativelntege Value indicates the number quantityOfChildren r of unique next lower level trade items contained in a complex trade item A complex trade item can contain at least 2 different GTINs N A Coreltem Attribute totalQuantityOfNextLow nonNegativelntege This represents the Total totalQuantityOfNext erLevelTradeltem r quantity of next lower level LowerLevelTradelte trade items that this trade m item contains Contains DI Coreltem ChildTradeltem ChildGTIN gtin A trade item in the item This is the actual childGTIN Package generalization hierarchy level i
2. Required Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public GS1 GDSN Content Attribute Attribute Role initialManufacturerSterilizationCode Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 215 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline MedicalDeviceTradeltemModule Module Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates transmissible agents such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene Code List Name SterilisationTypeCode Population Guidance below This GDSN attribute is a code list If a value is published in GDSN it indicates that the device is sold as being sterile Therefore if a value is published in the GDSN attribute initialManufacturerSterilizationCode then a value of TRUE will be populated in the GUDID If no value is published in GDSN then a value of FALSE will be p
3. Datatype Secondary Class N A Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 161 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of a value of DIRECT_PART_MARKING in GDSN Attribute additionalTradel teml dentificationTypeCode or any value in the AVP attribute directPartMarking This GUDID attribute is a Boolean and as such requires a TRUE or FALSE flag as a value If there is a value populated for the GDSN attribute combination of additionalTradelteml dentificatonTypeCode of DIRECT_PART_MARK and an associated value populated for additionalTradeltemldentificaton then the logical value for the GUDID is TRUE OR If there is a value populated for the AVP attribute directPartMarking then the logical value for the GUDID is TRUE else this value is FALSE 6 17 DPM DI Number FDA GUDID Description An identifier that is marked directly on the medical device and is different than the Primary DI Number only applicable to devices subject to Direct Marking requirements under 21 CFR 801 45 Data Entry Notes Enter Direct Marking DI Number Data type and field length are determined by the individual Issuing Agency
4. Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 185 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description Name associated with the three letter Product Code Required Auto Populated Data Type amp Length N A Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role Auto Populated by FDA for the GUDID based on the Product Code Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the Product Code submitted 6 36 FDA Listing Number FDA GUDI D Description Number assigned by FDA during Registration and Listing to all devices in commercial distribution regardless of pre market authorization requirements per 21 CFR 807 28 f Data Entry Notes Enter all relevant listing numbers that enable the labeler to commercially distribute the given version or model of device Listing number is optional for HCT P devices Kits and IVDs with a BLA premarket number Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required Unless device is an HCT P kit or IVD with a BL premarket submission number Data Type a
5. GS1 GDSN Public Public Private Status Content Attribute Role Datatype Secondary Class Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 212 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Multiplicity Occurrence Definition Code List Name Population Guidance below Potential UoMs for these storage and handling values are listed in Section 5 FDA GUDID mapping to GS1 code values under the UoM portion GS1 GDSN for the GUDID temperature values Module TradeltemTemperaturelnformationModule Content Attribute Attribute Role temperatureMeasurementUnitCode Datatype Secondary Class Code Multiplicity Mandatory If Module invoked Occurrence Single Definition Any standardized reproducible unit that can be used to measure any physical property Code List Name TemperatureMeasurementUnitCode GS1 GDSN for the GUDID humidity values Module N A Content N A Attribute Role N A Datatype Secondary Class Data Pool to always populate with a value of Percentage or Percent Multiplicity N A Occurrence N A Definition N A Code List Name N A GS1 GDSN for the GUDID pressure values use of any of these attributes below will point to GUDID pressure values Module AVP Content Attribute Role storageEnviro
6. Population Guidance below The GUDID is asking for a DUNS number for the Labeler This value will be for the Company as listed on the label For GDSN the Labeler is equivalent to the Brand Owner Brand Owner GLN is Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 151 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline a GDSN Mandatory field and the additional Party Identification attributes will be linked to the Brand Owner GLN specifically Population of this value can be accomplished by populating the code values DUNS or DUNS PLUS FOUR in the GDSN attribute additionalPartyl dentificationTypeCode tied to the attribute Brand Owner GLN The actual DUNS or DUNS_PLUS_ FOUR number can then populated in the GDSN attribute AdditionalPartyl dentification The number populated in AdditionalPartyl dentification will be populated in GUDID as the Labeler DUNS Number The FDA will utilise the Labeler DUNS to retrieve the company name and address from D amp B Should the FDA GUDID display an incorrect address the Labeler must contact D amp B to have necessary corrections made According to the FDA the address information retrieved from D amp B must match the Manufactured By statement on the device or its packaging The Manufactured By statement refers to the entity responsible for the label its contents and any regulatory filings This entity ma
7. Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 82 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Clinically Relevant Size Size Type AVP clinicalSizeType Code AVP clinicalSizeType clinicalSizeType Size Value AVP clinicalSizeValue Measurement AVP clinicalSizeValue clinicalSizeValue UoM and clinicalSizeValueUo M Size Unit of AVP clinicalSizeValue Measurement AVP clinicalSizeValue Measure clinicalSizeValue UoM and clinicalSizeValueUo M Size Type AVP clinicalSizeText String When the clinicalSizeType is AVP clinicalSizeText Text SPL coded as clinicalSizeText Name Size DEVICE_SIZE_TEXT_SPECIF Text Y this is the text used to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user Storage and Handling Storage and Tradeltem Attribute temperatureQualifierCo Code Code qualifying the type of a storageHandlingTem Handling Temperat de temperature requirement for peratureMaximum Type urel nform example Storage storageHandlingTem ationModu peratureMinimum le transportationMaxim umTemperature transportationMinim umTemperature Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 83 of
8. Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline A value populated of PRODUCTION_DATE for the GDSN attribute tradeltemDateOnPackagingTypeCode signifies that the item has as one of its controls a manufacture date It also signifies that the manufacture date will be printed on the packaging and be contained in the UDI 6 43 Serial Number FDA GUDID Description Indicates the device is managed by serial number This number can be found on the device label or packaging The serial number is assigned by the labeler and should be specific to each device Data Entry Notes Choose Yes No from the drop down list Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role serialNumberLocationCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition The location on the item or packaging of a serial number A serial number is a code numeric or alphanumeric assigned to an individual instance of an entity for its lifetime for example a Microscope model AC 2 with serial number 1234568 and microscope model AC 2 with serial
9. 1 The Global Language of Business Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Implementation guide for using the GDSN to populate a UDI database This version focuses on the U S FDA Global Unique Device Identifier Database GUDID Release 2 0 Ratified Oct 2015 Document Summary Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Document Item Document Name Current Value Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Document Date Oct 2015 Document Version 2 0 Document Issue Document Status Ratified Document Description Implementation guide for using the GDSN to populate a UDI database This version focuses on the U S FDA Global Unique Device Identifier Database GUDID Contributors Name Organisation Pete Alvarez GS1 Global Office Scott Brown GS1 US John Ryu GS1 Global Office Log of Changes Release Date of Change Changed By Summary of Change 1 09 Sep 2013 Pete Alvarez Merger of sections created by Pete Alvarez Global Office and Scott Brown GS1 U S 2 06 J an 2014 Scott Brown Updated section GDSN to GUDI D Attribute Mapping and Guidance on Populating Attributes per latest FDA GUDID requirements and User Guide 3 08 J an 2014 Final Review prior to submitting into the GS
10. Commercial Distribution Status FDA will populate based on the publication date AVP fDAGUDI DPublishD ate or final deployment attribute uDI DPublishDate and the discontinueDate at the GDSN each level Alternative or Additional Identifiers Direct Marking DM AVP isTradeltemExemptFro mDirectPartMarking Device Subject to Direct Marking DM but Exempt DM DI Different from Primary DI DM DI Number AVP directPartMarking Boolean Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the target market String This is a number or marking placed directly on the medical device AVP isTradeltemExempt FromDirectPartMar king LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of a value of DIRECT_PART_MA RKING in additionalTradel te ml dentification AVP directPartMarking isTradel temExemptF romDirectPartMarkin g Data Pool to default on outbound message directPartMarking Secondary DI Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 69 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name
11. Height UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimeters Measure and netContent Height UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Height UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Height UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Height UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure and netContent Height UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Height Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 123 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline
12. GDSN Notes GDSN v2 8 Attribute Name Device Packaged as Sterile MedicalDe viceTradel temModul e Attribute initialManufacturerSteril isationCode Code Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates transmissible agents such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates transmissible agents such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene LOGI CAL POPULATION Logical BOOLEAN value of TRUE from the population of any value in initialManufacturer Sterilisation initialManufacturerSt erilisation Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 89 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI
13. Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV N A New DI Trigger NO Public Private Status Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 28 of 218 Data Element Labeler DUNS Number Description Business number issued by Dun amp Bradstreet D amp B that is used to associate the Labeler Company name and address to a given version of model of a device in GUDID Data Entry Notes Choose appropriate DUNS Number from drop down LOV To ensure data consistency for the GUDID DUNS number submitted to the GUDID should associate to the company name that appears on the device label ideally the address associated with the DUNS number should also match the address on the device label but since address is not displayed to the GUDID public user this is not a requirement for data consistency All edits to information connected to the Labeler DUNS Number must be done through Dun amp Bradstreet No edits of DUNS information will be permitted in the GUDID Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Edit Editing of entered data is allowed Other Labeler DUNS listed to your GUDID account can be selected No Edit Editing of
14. actual term from a mapping to the GMDN or FDA Preferred term listing SPL Name GDSNTrad Attribute additionalTradeltemCla Code The Classification System for Use code 63 additionalClassificati FDA Preferred eltemClas ssificationS ystemCode the Additional Trade Item onAgencyName Term Code sification Classification SPL Name Tradeltem Attribute additionalTradeltemCla AdditionalTradelte Category code based on Code value additionalClassificati FDA Preferred Classificati ssificationCode mClassificationCod alternate classification managed by onCategoryCode Term Code on e schema chosen in addition to GMDN FDA Only Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 78 of 218 FDA GUDID Module Content Data Element Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Name GDSNTrad Attribute additionalTradeltemCla string Text 1 200 Description of the additional FDA will populate additionalClassificati eltemClas ssificationCodeDescripti Characters classification bundle based on the onCategoryDescripti sification on code agency description GMDN Code Can on be provided via GDSN for supply chain purposes but will not be populated to the GUDID from GDSN Definition FDA will populate based on the GMDN Code provided Device Char
15. either GMDN PT Code or FDA PT Code Data Type amp Length Type Num Length 5 SPL Text Alphanumeric 5 Entry List of Values LOV N A New DI Trigger NO Public Private Status Private GS1 GDSN requires 2 GDSN attributes to denote the GUDID FDA Premarket Submission Number Module GDSNTradeltemClassification Content Attribute Attribute Role AdditionalTradel temClassificationS ystemCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition The Classification System for the Additional Trade Item Classification Code List Name a a 35 for GMDN or 65 for FDA PT ode Module TradeltemClassification Content Attribute Attribute Role additionalTradeltemClassificationCode Datatype Secondary Class AdditionalTradel temClassificationCode Multiplicity Optional Occurrence Multiple Definition Category code based on alternate classification schema chosen in addition to the Global Product Classification GPC Code List Name N A Population Guidance below This repeatable set of attributes will allow for the population of a GMDN Code or a FDA PT Code for the device This can be accomplished by the population of the code value 35 for GMDN and or 65 for FDA PT Code in the GDSN attribute AdditionalTradeltemClassificationSystemCode The actual GMDN Code or FDA PT Code can then be populated using the associated val
16. 100 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN requires 3 GDSN attributes to denote the GUDID Customer Contact Email Module TradeltemContactInformation Content Attribute Attribute Role contactTypeCode Datatype Secondary Class Code Multiplicity Mandatory if Module invoked Occurrence Single Definition The general category of the contact party for a trade item for example Purchasing Code List Name ContactTypeCode CONSUMER_SUPPORT Module CommunicationChannel Content Attribute Attribute Role communicationChannelCode Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 176 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline CommunicationChannel Module Datatype Secondary Class Code Multiplicity Mandatory if Module invoked Occurrence Single Definition Code specifying the type of communication channel for example TELEPHONE Code List Name CommunicationChannelCode TELEPHONE Module CommunicationChannel Content Attribute Attribute Role communicationChannelValue Datatype Secondary Class String Text 1 200 Characters Multiplicity Mandatory if Module invoked Occurrence Single Definition Text identifying the endpoint for the communication channel for example a telephone number or an e mail address C
17. After the grace period ends on day 8 this attribute can be added but cannot be edited or deleted Size Value FDA GUDID Description Numeric value for the clinically relevant size measurement of the medical Data Entry Notes Enter numeric value for size Edit Rules After Grace Period Add Addition of new data is allowed device Decimals are accepted fractions are not accepted Each Size Value should be entered separately GUDID is not accepting Size Value as a range at this time Required Conditionally Required Required if device is available in more than one size Data Type amp Length Type Num Length 40 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module AVP Content Attribute Role clinicalSizeValue actual AVP name ends in 1 2 3 or 4 to allow grouping of AVP attributes Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The value to denote the dimensional size which is clinically relevant for the use of the Code List Name UN Recommendation 20 trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeType It will be deployed into the GDSN Schema in 2016 17 into a final solution All o
18. Attribute Role mRI CompatibilityCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition This is an identification of the compatibility of a trade item for use in the presence of a Magnetic Resonance Imaging MRI system Code List Name MRICompatibilityCode Population Guidance below This GDSN attribute is a code list of values signifying if the device is safe for use in an MRI environment All GDSN code values map to an applicable GUDID code values When MRI_COMPATI BLE is populated in GDSN the value of MR Conditional will be provided to the GUDID When UNSPECIFIED is populated in GDSN the value of Labeling does not contain MRI Safety Information will be provided to the GUDID Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 199 of 218 6 51 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Size Type FDA GUDID Description Dimension type for the clinically relevant measurement of the medical device Data Entry Notes Choose a value from the drop down LOV If the desired Size Type is not in the current list select Size Text specify an
19. Code Name Definition Lot or Batch Number Manufacturing Date Serial Number Expiration Date Donation Identification Number Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 Device labeled as Not made with natural rubber latex Size Type Text and Unit of Measure Updated the GUDID Data Entry Notes field with updated notes for Issuing Agency Primary DI Number Device Count Unit of Use DI Number Labeler DUNS Number Company Name Company Physical Address Brand Name Version or Model Catalog Number DI Record Publish Date Commercial Distribution End Date Commercial Distribution Status Heading Direct Marking DM Device Subject to Direct Marking DM but Exempt DM DI Number Issuing Agency Secondary DI Number Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date Package Status Customer Contact Phone Customer Contact Email Human Cell Tissue or Cellular or Tissue Based Product HCT P Kit Combination Product Device Exempt from Premarket Submission FDA Premarket Submission Number Supplement Number Product Code Product Code Number FDA Listing Number Code Name Definition For Single Use Lot or Batch Number Manufacturing Date Serial Number Expiration Date Donation Identification Number Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 Device labeled as
20. Element after Grace Period When a GUDID attribute appears on the medical device package label the values submitted to the GUDI D should match the value on the label Trigger Status Device Information Device Identifier DI Information Issuing Organization accredited by FDA to Choose a value from None NO edit add or Required NA GS1 HIBCC YES Public Agency operate a system for the issuance of the drop down LOV delete are allowed ICCBBA UDIs Primary An identifier that is the main Enter the Device None NO edit add or Required Type N A YES Public DI primary lookup for a medical Identifier DI delete are allowed Num or Number device and meets the requirements Number Alphanum to uniquely identify a device through Data type and field its distribution and use The primary length are Length DI number will be located on the determined by the min 6 base package which is the lowest individual Issuing max 23 package level of a medical device Agency structure containing a full UDI For medical defined devices without packaging the GS1 Numeric by Issuing primary DI number and full UDI may Num with 14 Agency be on the device itself digits structure HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Device Number of medical devices in the Enter the number of None NO edit add or Required Type N A YES Public Count base package
21. FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition Units of Measure Pressure tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi nimum UoM transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Length um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure Pore and netContent Size UoM Pressure psi Pound per storageEnvironmentA Pressure 80 Pound per square Psia pound force per square inch absolute is a Units of Square Inch tmosphericPressureM inch Absolute unit of pressure relative to a vacuum such as that Measure aximum UoM in space At sea level Earth s atmosphere actually Pressure storageEnvironmentA exerts a pressure of 14 7 psi Humans do not feel tmosphericPressureMi this pressure because internal pressure of liquid in nimum UoM their bodies matches the external pressure If a transportationEnviron pressure gauge is calibrated to read zero in space mentAtmosphericPres then at sea level on Earth it would read 14 7 psi sureMaximum Thus a reading of 30 psig on Earth on a tire
22. GS1 GDSN Module AVP Content Attribute Role donationl dentificationNumberMarked Datatype Secondary Class Boolean Multiplicity Optional Occurrence Single Definition Indicates the device is managed by a Donation Identification Number This number can be Code List Name found on the device label or packaging The Donation Identification Number is applicable to devices that are also regulated as HCT Ps and is a number that is assigned to each donation N A Population Guidance below This attribute has a temporary attribute AVP in GDSN donation dentificationNumberMarked It will be deployed into the GDSN Schema in 2016 17 into a final solution This GUDID attribute is a Boolean clarifying how the item is controlled It is not for the population of actual Donation Identification Numbers Neither the GUDID nor GDSN are used to provide actual Donation Identification Numbers These should be communicated in transactional documents such as packaging shipping and invoice documents 6 46 Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 FDA GUDI D Description Data Entry Notes Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801 437 Choosing Yes indicates that the device label or packaging contains one of the following statements 1 Caution This Product Contains Natural Rubber L
23. Indicates the type of date marked on the packaging for example Best Before Date LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of either values of EXPIRATION_DATE or BEST_BEFORE_DA TE in tradeltemDateOnP ackagingTypeCode other values or when no value is provided would equate to a value of FALSE packagingMarkedEx pirationDateType Donation Identification Number AVP Latex Information donationl dentificationN umberMarked Boolean Indicates the device is managed by a Donation Identification Number This number can be found on the device label or packaging The Donation Identification Number is applicable to devices that are also regulated as HCT Ps and is a number that is assigned AVP donationl dentificati onNumberMarked donationl dentificatio nNumberMarked Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 81 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Device Healthcar Attribute doesTradeltemContainL NonBinaryLogicEnu An indication that the trade This definition is doesTradel temCont required to be eltemInfo atex meration item has a positive latex currently listed on ainLatex labeled as rmationM r
24. Oct 2015 Enter a number for High Value Must enter at least one value Low or High but can enter both Low Value and High Value if needed When Storage and Handling value is a range this is the higher end of that range When Storage and Handling value is greater than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling Low Value Choose a value from the drop down LOV Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed 2015 GS1 AISBL Conditional ly Required One value Low or High is required if Storage and Handling Type is added to the device record Conditional ly Required Required if Storage and Handling Type is added to the device record Type Num Length 6 NA NA Degrees Celsius Degrees Fahrenheit Degrees Kelvin Kilo Pascal Percent Relative Humidity Millibar NO NO Public Public Page 61 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size The two Sterilization Method questions are independent of each othe
25. PI UDI GTIN or GTIN Al s UDI The United States Food and Drug Administration is the first regulator to issue an UDI rule In addition the U S FDA operates a database called Global Unique Device Identifier Database GUDID designed to store medical device product data For more information on the U S FDA UDI and GUDID and how GS1 standards support it refer to the UDI page on the GS1 US website Master Data Management and Governance One of the most challenging areas related to implementation of the UDI regulation is the Master Data Management and Governance Master Data Management and Governance MDM amp G refers to a series of processes and protocols that should exist within an organisation to create enrich maintain and publish product information within and outside the enterprise Equally important is data quality management which is a complementary cycle of activities aimed to ensure that the subject information meets high standards of quality and reliability In short the data created by the product s Brand Owner must meet the requirements of the intended use case Medical device data which has to comply with UDI regulation is no exception Completeness and accuracy of product data is the responsibility of the Brand Owner Each Brand Owner should have an internal process to manage the data required by the regulator This includes data quality checks and procedures data management process and policies enterpri
26. Ratified Oct 2015 2015 GS1 AISBL Page 217 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidance below The GDSN attribute initialSterilirilizationPrior oUseCode is a code list indicating the type s of sterilization which should be performed on a device by a Provider prior to use Population of a value for this attribute signifies that the device is not sold as sterile and that the Provider does need to sterilize it prior to use using the method populated When this attribute is published a value of TRUE will be populated for the GUDID attribute Requires Sterilization Prior to Use The value specified will be provided to the GUDID as the Sterilization Method It is recommended to not use the value of UNSPECIFIED as the FDA GUDID will not accept that value Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details Note Until the GDSN release can add these code values into the sterilisationMethodCodeList the GDSN AVP attribute for extended nitialSterilzationPriorToUse can be used for them with these code values Chlorine_Dioxide Dry_ Heat High_Intensity_Or_Pulse_Light Microwave_Radiation Sound_Waves High_Level_ Disinfectant Liquid_Chemical Nitrogen_Diox
27. Size Units of height width depth millimeters Measure and netContent Circumference UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Circumference UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Circumference UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Circumference UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure and netContent Circumference UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Circumference UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height width depth International System of Units SI Measure and netContent Circumference Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 120 of 218 Leveraging GDS
28. and netContent Outer Diameter UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Outer Diameter UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height width depth International System of Units SI Measure and netContent Outer Diameter Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 128 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Outer Diameter UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Outer Diameter UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Outer Diameter UoM Len
29. and spelling changes throughout this section All changes are in red text and highlighted in yellow Some changes denote a difference in the FDA GUDID Webtool Guidance and Guidance for the use of HL7 SPL messaging machine connection to the FDA GUDID To aid readability and Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 3 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline printability pagination was also changed to allow for each different attribute to start a new page Updated Section 7 page 261 added a reference to a companion GS1 US document which is a spreadsheet mapping tool Specific changes based on changes made in companion GS1 US documentation are listed below These specific changes match to the general summary changes listed above Updated attribute name for the additional classification agency to correct attribute name of additionalClassificationAgencyName Updated the guidance for the attribute manufacturerDeclaredReusabilityType to reflect changes made to the code list tab in the previous version of this sheet Change the code list mapping for the UNKNOWN code value for the serialNumberLocationCode to be TRUE for the GUIDE Corrections to the sheet Added an AVP for the FDA Medical Device Listing Number which was missing from the sheet Removed extraneous word Maximum in the GDSN attributes for the transportat
30. data quality data policies and risk management and executive sponsorship The process should ensure that certain data assets are formally recognized and managed throughout the organisation Data Governance is a critical component of Master Data Management and especially important to the accuracy of the data requirements of a UDI regulation Each Brand Owner is responsible for submitting and maintaining their data in the UDI database Data Governance should include the decision rights and accountability of the key pillars Executive Internal sponsors of the Master Data Management process within an organisation executive management Legal Legislative Internal sponsors responsible for the representation of regulatory affairs as it relates to information management and publication in both internal and external systems and databases This includes legal compliance legislative and regulatory requirements This is especially important with UDI regulation Administrative Internal function responsible for the maintenance of the Master Data The function can be either centralized or decentralized Refer to the Roles and Responsibilities section of this document for more information in functional responsibilities Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 22 of 218 1 9 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Roles and Responsibiliti
31. if Requires Sterilizatio n Prior to Use is marked Yes NA Chlorine Dioxide Dry Heat Ethylene Oxide High Intensity Light or Pulse Light Hydrogen Peroxide Microwave Radiation Moist Heat or Steam Ozone Peracetic Acid Radiation Sound Waves Ultraviolet Light NO Public Page 64 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN to FDA GUDID Mapping Population of the FDA GUDID through the use of a GS1 GDSN message and a GDSN Certified Data Pool as a Third Party requires an understanding of the GDSN and its attributes While many of the FDA GUDID attributes can be mapped one to one with a GS1 GDSN equivalent there are others that do not map and are logically populated or map via more than one GDSN attribute The first table below provides a mapping between the FDA GUDID attribute list and the corresponding GS1 GDSN Attribute s The attributes listed in the table use the name assigned in the GDSN standards Each user of this document should consult with their GDSN Certified Data Pool for the exact naming convention and message formatting applicable to the contract between the user and the Data Pool The second table below provides a mapping between the FDA GUDID code values and the corresponding GS1 GDSN code values The values listed in the table use the name assigned in the GDSN standards Each user of this docu
32. or Model If the device does not have a version model or catalog number enter a concept that can be used to identify all devices that have specifications performance size and composition within limits set by the labeler Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Alphanum Length 40 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN requires 2 GDSN attribute to denote the GUDID Version or Model Module AdditionalKeyDataTypes Content Attribute Attribute Role additionalTradelteml dentificationTypeCode Datatype Secondary Class Code Multiplicity Mandatory If module is invoked Occurrence Single Definition This code will be used to cross reference the Vendors internal trade item number to the GTIN in a one to one relationship Code List Name AdditionalTradeltemldentificationTypeCode MODEL_NUMBER Module GS1ldentificationComponents Content Attribute Attribute Role additionalTradel teml dentification Datatype Secondary Class AdditionalTradeltemldentification Multiplicity Mandatory If module is invoked Occurrence Single Definition Alternative means to the Global Trade Item Number to identify a trade item Code List Name N A Population Guidance below The GUDID is asking for a Model Number for the device This can b
33. 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name High Value Tradeltem Attribute maximumTemperature TemperatureMeasu The maximum temperature storageHandlingTem SPL Name Temperat rement that a trade item can be held peratureMaximum Storage and urel nform below defined by the transportationMaxim Handling High ationModu manufacturer without umTemperature Value le affecting product safety or quality Low Value Tradeltem Attribute minimumTemperature TemperatureMeasu The minimum temperature storageHandlingTem SPL Name Temperat rement that a trade item can be held peratureMinimum Storage and urel nform below defined by the transportationMinim Handling Low ationModu manufacturer without umTemperature Value le affecting product safety or quality Unit of Measurem Attribute temperatureMeasureme Code Any standardized storageHandlingTem Measure SPL entandQu ntUnitCode reproducible unit that can be peratureMaximum Name antityData used to measure any storageHandlingTem Storage and Types physical property peratureMinimum Handling Unit transportationMaxim of Measure umTemperature transportationMinim umTemperature Storage and AVP storageEnvironmentAt Measurement The maximum pressure at AVP st
34. Code Definition UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Lumen Inner Diameter UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height width depth International System of Units SI Measure and netContent Lumen Inner Diameter UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Lumen Inner Diameter UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Lumen Inner Diameter UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Lumen Inner Diameter UoM Length um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure and netContent Lumen Inner Diameter UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Siz
35. Codeset While the GMDN Code will not be published on the FDA GUDID Portal the applicable GMDN Preferred Term will be published 6 38 Name FDA GUDID Description Name associated with the GMDN Preferred Term Code FDA PT Code Data Entry Notes System populated based on GMDN Preferred Term Code FDA PT Code Edit Rules After Grace Period NA data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length NA Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role additionalTradeltemClassificationCodeDescription Datatype Secondary Class String Text 1 200 characters Multiplicity Optional Occurrence Single Definition Description of the additional classification bundle code agency description Code List Name N A Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the GMDN Preferred Term Code submitted Publishing the description field with the classification code name or description in GDSN will provide additional value to supply chain partners receiving GDSN messages The population of a GMDN Code via GDSN has been available for some time While the FDA will not make the code available to the Public in the GUDID GDSN will pass the code along
36. Contact Phone Support Contact Email Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Size Type Size Value Size Unit of Measure Size Type Text Storage and Handling Type High Value Low Value Unit of Measure Sterilization Method Updated the GUDID Cardinality field with the SPL Text for Device Subject to Direct Marking DM but Exempt DM DI Number Secondary DI Number Package DI Number Contains DI Package Support Contact Phone Support Contact Email Device Exempt from Premarket Submission FDA Premarket Submission Number Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Page 9 of 218 Release Date of Change Release 2 0 Ratified Oct 2015 Changed By 2015 GS1 AISBL Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Summary of Change Safety Status Size Type Size Value Size Unit of Measure Size Type Text High Value Low Value Unit of Measure Special Storage Conditions Sterilization Method Updated the GUDID Data Type field with the SPL Text for Version or Model Number Device Description DI Record Publish Date Note date format is different between the Web Portal and the SPL Message Commercial Distribution End Date Note date format is different between the Web Portal and
37. Cylinder Envelope Gable Top A rigid cylindrical container with straight sides and circular ends of equal size A predominantly flat container of flexible material having only two faces and joined at three edges to form an enclosure The non joined edge provides a filling opening which may later be closed by a gummed or adhesive flap heat seal tie string metal clasp or other methods A rectangular shaped non stackable package designed primarily for liquids such as juice or milk Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 112 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute Description where Code Group applicable Package Type Jug packagingTypeCode JG Jug A container normally cylindrical with a handle and or a lid or spout for holding and pouring liquids Package Type Jar packagingTypeCode JR Jar A rigid container made of glass stone earthenware plastic or other appropriate material with a large opening which is used to store products e g jams cosmetics Package Type Multipack packagingTypeCode MPG Multipack A bundle of products held together for ease of carriage by the consumer A multipack is always a consumer unit Package Type Not packed packagingTypeCode NE Not packed The item is provided without packagin
38. Enter the Catalog or Reference Number Catalog Reference number can also serve as Version Model if it represents the devices that have specifications performance size and composition within limits set by the labeler Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional Data Type amp Length Type Alphanum Length 40 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN requires 2 GDSN attribute to denote the GUDID Catalog Number Module AdditionalKeyDataTypes Content Attribute Attribute Role additionalTradelteml dentificationTypeCode Datatype Secondary Class Code Code List Name Multiplicity Mandatory If module is invoked Occurrence Single Definition This code will be used to cross reference the Vendors internal trade item number to the GTIN in a one to one relationship AdditionalTradeltemldentificationTypeCode SUPLIER_ASSIGNED Module GS1ldentificationComponents Content Attribute Attribute Role additionalTradel teml dentification Datatype Secondary Class AdditionalTradeltemldentification Multiplicity Occurrence Mandatory If module is invoked Single Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 156 of 218 Leveraging
39. GDSN Content Attribute Attribute Role brandName Datatype Secondary Class string Text 1 70 Characters Multiplicity GDSN Mandatory Occurrence Single Definition The recognizable name used by a brand owner to uniquely identify a line of trade item or services This is recognizable by the consumer Code List Name N A Population Guidance below This should be the most recognizable brand on the package trade item If there is no brand on the package trade item this should be the brand name under which the item is sold Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 154 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 9 Version or Model FDA GUDID Description The version or model found on the device label or accompanying packaging used to identify a category or design of a device The version or model identifies all devices that have specifications performance size and composition within limits set by the labeler Data Entry Notes Enter the Version or Model Version Model can be any distinguishing string of letters and or numbers Catalog Number can be entered if device does not currently have a Version
40. GDSN Temporary population until final GDSN deployment AVP Content Attribute Role exemptFromFDAPreMarketAuthorization Datatype Secondary Class Boolean Multiplicity Optional Occurrence Single Definition Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices Class III devices are those that support or sustain human life are of substantial importance in preventing impairment of human health or which present a potential unreasonable risk of illness or injury Due to the level of risk associated with Class III devices FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices Therefore these devices require a premarket approval PMA application under section 515 of the FD amp C Act in order to obtain marketing clearance Please note that some Class Ill preamendment devices may require a Class III 510 k See Historical Background2 for additional information Code List Name N A Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 180 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidance below This attribute has a temporary attribute AVP in GDSN exemptFromFDAPreMarketAuthorization It will
41. GDSN certified Data Pool What is UDI and G UDID The Unique Device Identifier UDI is a multinational initiative driven by several medical device regulators with the intention of improving patient safety and healthcare business processes Each UDI regulation is expected to include a database which will contain medical device product data This is referred to as a Unique Device Identifier Database UDID For more information in UDI at a global level and how GS1 standards support it refer to the UDI page on the GS1 website The Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 19 of 218 1 5 1 6 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline illustration below provides a basic cross reference between UDI terms and the corresponding GS1 standard Figure 1 1 UDI Unique Device Identification UDID Data Elements linked to the Device Identifier gt Device Identifier DI GS1 Standards Product Identification GDSN Attributes mapped to each UDID data element GTIN Global Trade Item Number H a re ae 4 Production data is not stored in UDI or GDSN databases od Al Production Identifier PI if applicable i Application Identifiers Al Production Identifier data will vary by e Expiration Date Al 17 e g 141120 medical device type and manufacturer i Lot Batch Al 10 e g 1234AB current practice Serial Number Al 21 e g 12345XYZ DI
42. GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1ldentificationComponents Module Definition Alternative means to the Global Trade Item Number to identify a trade item Code List Name N A 6 11 Data Entry Notes Enter device description Population Guidance below The GUDID is asking for a Catalog Number for the device This can be accomplished by the population of the code value SUPPLIER_ASSIGNED in the GDSN attribute additionalTradelteml dentificationTypeCode The actual Catalog Number can then be populated in the GUDID using the associated additionalTradeltemldentification The code value of SUPPLIER_ASSIGNED is defined as The additional Trade Item Identification value populated has been developed and assigned by the party which provides service s and or manufactures or otherwise has possession of the goods and consigns or makes them available in trade This number is a base model or style number assigned to the product and may be the same for several GTINs where they are variations of each other For example a coffee mug with 3 GTINs one each for the brown mug the white mug and the black mug might all be the supplier assigned number of AB123 Use of this value is recommended in the absence of a Model Number or Manufacturer s Part Number This group of attributes will be used to provide several sets of information and as such will be repeated as a group GUDID
43. GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Sterilization Method Ultraviolet Light initialSterilisationPrior ToUseCode UV_LIGHT Useful for sterilisation of surfaces and some transparent objects Many objects that are transparent to visible light absorb UV UV irradiation is routinely used to sterilize the interiors of biological safety cabinets between uses For Single Use FALSE manufacturerDeclared LIMITED_REUSABLE Manufacturer has indicated that product may be ReusabilityTypeCode reused but has provided special instructions limitations or guidelines around the reuse of this trade item For Single Use FALSE manufacturerDeclared REUSABLE Product can be reused ReusabilityTypeCode For Single Use TRUE manufacturerDeclared REUSABLE_SAME_PATIENT Product can only be reused for the same patient ReusabilityTypeCode For Single Use TRUE manufacturerDeclared SINGLE_USE Item is not intended to be reused ReusabilityTypeCode What MRI MR Safe mRICompatibilityCode MRI_SAFE Indicates that the healthcare trade item is safe to safety use within a Magnetic Resonance Imaging MRI information system does the labeling contain What MRI MR Unsafe mRICompatibilityCode MRI_UNSAFE Indicates that a
44. GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a and Handling Celsius eratureMaximum temperature scale the freezing point of water is 0 Units of UoM degrees Celsius C and the boiling point 100 C Measure storageHandlingTemp at standard atmospheric pressure placing the Storage eratureMinimum boiling and freezing points of water exactly 100 Environment UoM degrees apart Humidity transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to and Handling eratureMaximum 1 273 16 of the absolute temperature of the triple Units of UoM point of water One kelvin degree is equal to one Measure storageHandlingTemp Celsius degree Storage eratureMinimum Environment UoM Humidity transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling Units of Measure Storage Environment Humidity tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi nimum UoM transportationEnviron mentAtmosphericPres su
45. Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Depth Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 121 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Depth UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Depth UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure and netContent Depth UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Depth UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height w
46. N A New DI Trigger NO Public Private Status Public GS1 GDSN Module ConsumerlnstructionsModule Content Attribute Attribute Role consumerStoragel nstructions Datatype Secondary Class Description1000 Free Text 1 1000 Characters Language Qualified Multiplicity Optional Occurrence Multiple Definition Expresses in text the consumer storage instructions of a product which are normally held on the label or accompanying the product This information may or may not be labeled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement Allows for the representation of the same value in different languages Code List Name Language Code ISO 639 Population Guidance below This attribute can be populated with any special storage transportation or handling instructions as deemed necessary by the Brand Owner 6 59 Device Packaged as Sterile FDA GUDI D Description Indicates the medical device is free from viable microorganisms See ISO TS 11139 Data Entry Notes Choose Yes No from the drop down list The two Sterilization Method questions are independent of each other this element is designed to capture information about the device as it enters Commercial Distribution These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler Edit Rules After Grace Period None NO edit add or delete are allowed
47. Not made with natural rubber latex Prescription Use Rx Over the Counter OTC MRI Safety Information Size Type Size Value Size Type Text Storage and Handling Type High Value Low Value Unit of Measure Special Storage Conditions Device Packaged as Sterile Requires Sterilization Prior to Use and Sterilization Method Updated the GUDID Edit Rules after Grace Period and GUDID Required in Database fields for all GUDID Attributes Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 7 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Release Date of Change Changed By Summary of Change Change name of the GUDID Required column to be GUDID Required in Database Removed the GUDID Cardinality column Merged the GUDID Data Type and GUDID Length columns into one column titled GUDID Data Type amp Length Updated the values for all GUDI D attributes for the Data Type and Length column Updated the column heading GUDID Values Terminology to be GUDID Entry List of Values LOV Updated the values for all GUDI D attributes for the GUDID Entry List of Values LOV column Updated the New DI Trigger field for the attributes Requires Sterilization Prior to Use Added new attribute information for the attribute Donation Identification Number Marked the attribute Is the device labeled for MRI Safety as being deleted Removed columns L and
48. Notes Choose a value from the drop down LOV Only applicable if the answer to Requires Sterilization Prior to Use is Yes otherwise the LOV will remain inactive The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required if Requires Sterilization Prior to Use is marked Yes Data Type amp Length NA Entry List of Values LOV Chlorine Dioxide Dry Heat Ethylene Oxide High Intensity Light or Pulse Light Hydrogen Peroxide Microwave Radiation Moist Heat or Steam Ozone Peracetic Acid Radiation Sound Waves Ultraviolet Light New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role initialSterilisationPriorToUseCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition This is an indication of the type s of sterilisation that is required to be completed by a healthcare provider prior to initial use of the healthcare trade item Sterilisation refers to any process that effectively kills or eliminates transmissible agent Code List Name SterilizationTypeCode Release 2 0
49. Page 204 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline TradeltemTemperaturelnformationModule Attribute Role temperatureQualifierCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Code qualifying the type of a temperature requirement for example Storage Code List Name TemperatureQualifierCode GS1 GDSN for the GUDID humidity values Module TradeltemHumidityInformationModule Content Attribute Attribute Role humidityQualifierCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Code qualifying the type of a temperature requirement for example Storage Code List Name TemperatureQualifierCode GS1 GDSN for the GUDID pressure values use of any of these attributes below will point to GUDID pressure values Module Content Attribute Role AVP storageEnvironmentAtmosphericPressureMaximum Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum pressure at which the trade item can be stored and handled This uses a measurement consisting of a unit of measure and a value Code List Name Module Content Attribute Role storageEnvironmentAtmosphericPressureMinimum Datatype Secondary Class Measurement Mul
50. Page 99 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Device TRUE initialManufacturerSter HYDROGEN_PEROXI DE Another chemical sterilizing agent It is relatively Packaged as ilisationCode non toxic once diluted to low concentrations Sterile although a dangerous oxidizer at high concentrations and leaves no residue Device TRUE initialManufacturerSter ETHANOL A chemical sterilisation method that utilises ethanol Packaged as ilisationCode as the sterilisation method Sterile Device TRUE initialManufacturerSter FORMALDEHYDE A chemical sterilisation agent used to provide Packaged as ilisationCode sterilisation Items being sterilized are usually Sterile immersed in the formaldehyde for a pre determined time period Device TRUE initialManufacturerSter GLUTERALDEHYDE A colourless liquid with a pungent odour used to Packaged as ilisationCode sterilize medical and dental equipment It is also Sterile used for industrial water treatment and as a chemical preservative Glutaraldehyde is an oily liquid at room temperature density 1 06 g mL and miscible with water alcohol and benzene Device TRUE initialManufacturerSter LIQUID_CHEMI CAL This is a code value for population with the AVP Packaged
51. Removed highlighted text and cells which represented the changes made between version 12 and 13 of this spreadsheet Updated sheet to reflect changes in the FDA Appendix B document posted on May 7 2014 All changes are noted with red text and a yellow highlighted cell Updated the GUDID Data Element field with Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 6 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline name changes for Version or Model Number to be Version or Model Device Description max 2000 characters to be Device Description DI Record Publish Date mm dd yyyy to be DI Record Publish Date Commercial Distribution End Date mm dd yyyy to be Commercial Distribution End Date Secondary DI Issuing Agency to be Issuing Agency Heading of Support Contact to be Customer Contact Support Contact Phone to be Customer Contact Phone Support Contact Email to be Customer Contact Phone and MRI Safety Status to be What MRI safety information does the labeling contain Updated the GUDID Description field with updated definitions for Primary DI Number Device Count Labeler DUNS Number Company Name Company Physical Address Version or Model DI Record Publish Date Heading Package DI Package DI Number Quantity per Package Contains DI Package Package Status Customer Contact Phone Customer Contact Email Supplement Number Product Code
52. Term Codes or FDA PT Codes Each device record must have at least one assigned GMDN Code FDA PT Code DI records are allowed gt 1 GMDN Code FDA PT Code if necessary Must enter GMDN Code OR FDA PT Code please don t enter both codes for the same GMDN Name and Definition For GMDN Codes Enter only the 5 digit number omit the P For FDA PT Codes Enter the 4 letter code The FDA PT Codes are assigned to each GMDN term used in place of a GMDN Code They enable labelers to assign a GMDN term to their GUDID submission until a GMDN Code can be obtained from the GMDN Agency The FDA PT Codes can be found in the Find FDA PT Code Module on the GUDID website For more information see the GUDID Final Guidance The FDA PT Codes can be found in the Find FDA PT Code Module on the GUDID website Changed section heading from Production Identifier s on Label to Production dentifier s in UDI Updated list of values for the FDS Attribute Size Unit of Measure Added Millibar for pressure and Removed Microgram per Total Volume Milligram per Total Volume Updated the GUDID Data Entry notes for the FDA Attribute Low Value to be Enter a number for Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 13 of 218 Release Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Date of Change Changed By Summary of Change Low Value Must enter at least one value Lo
53. Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Package Type Rack packagingTypeCode RK Rack A non specific term identifying a framework or stand for carrying holding or storing items Commonly on wheels and primarily used in the logistical functions to deliver items such as hanging garments or items on shelves such as dairy products and bakery items and flowers Package Type Reel packagingTypeCode RL Reel A spool on which thread wire film etc is wound Any device on which a material may be wound Usually has flanged ends and is used for shipping or processing purposes Package Type Stretchwrapped packagingTypeCode STR Stretchwrapped In packaging a high tensile plastic film stretched and wrapped repeatedly around an item or group of items to secure and maintain unit integrity The use of stretch film to tightly wrap a package or a unit load in order to bind protect and immobilize it for further handling or shipping Package Type Shrinkwrapped packagingTypeCode SW Shrinkwrapped In packaging a plastic film around an item or group of items which is heated causing the film to shrink securing the unit integrity The use of shrunken film to tightly wrap a package or a unit load in order to bind protect and immobilize it for further handling or shipping P
54. Units of cubic inches and is equal to exactly 3 785411784 Measure Total litres or about 0 133680555 cubic feet Volume UoM Volume pt_us Pint netContent Volume PTI Pint UK A pint UK is equal to 1 8 Gallon UK used Units of primarly as a measure for beer and cider when sold Measure Total by the glass Volume UoM Volume qt_us Quart netContent Volume QTD Quart US dry A US dry quart is equal to 1 32 of a US bushel Units of exactly 1 101220942715 litres Measure Total Volume UoM Volume cL Centiliter netContent Volume CLT Centilitre A centilitre is one hundredth 1 100 of a litre Units of Measure Total Volume UoM Volume dL Deciliter netContent Volume DLT Decilitre A decilitre is one tenth 1 10 of a litre Units of Measure Total Volume UoM Volume fL Femtoliter netContent Volume FML Femtolitre Femtolitre Femtolitre is the metric unit of volume Units of equal to one thousand trillionth European or one Measure Total quadrillionth American litre One femtolitre is the Volume same as one cubic micrometre m3 which can be represented numerically as 0 00000000000001 liter Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 144 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Name Code Definition Code Attribu
55. UoM and gauge represents an absolute pressure of 44 7 psi transportationEnviron Ib in mentAtmosphericPres sureMinimum UoM UoM Pressure Hz Hertz netContent Frequency HTZ Hertz A unit of frequency defined as the number of Units of complete cycles per second it is the basic unit of Measure frequency in the International System of Units SI Pressure UoM Pressure kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 131 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Pressure Units of Measure Pressure mbar millibar storageEnvironmentA tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi nimum UoM transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM Pressure MBR Millibar A hundred pascals 10 to the 2nd power UoM Pressure Units of Measure Pressure mg TotalVolume Milligram per Total Volume storageEnvironmentA tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi nimum UoM transportationEnviron mentAtmosphericPres sureMaximu
56. a single contactType There can be more than one contactType populated for a single Trade item For the GUDID the contactType of CONSUMER_SUPPORT will signify the information to be provided to the GUDID via GDSN Where an instance of the GDSN attribute communicationChannelCode is populated with the value of TELEPHONE the corresponding communicationChannelValue will map to the GUDID attribute Customer Contact Phone This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Customer Contact Phone and Customer Contact Email 6 27 Customer Contact Email FDA GUDID Description Email for the Customer contact to be used by patients and consumers for device related questions Data Entry Notes Enter email address This email address could be the same one that appears on the device labeling or the company website Labelers can identify a Customer Contact email and a Customer Contact phone number for each device record If a phone number is entered and you don t have a Customer Contact email please enter xx xx xx Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required ONLY required if Customer Contact Email is entered Data Type amp Length Type Alphanum Length
57. and nformatio should be stored in Handling High nModule Value Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 85 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Low Value Tradeltem Attribute minimumHumidityPerce Decimal The maximum humidity in storageHandlingHu SPL Name Humidityl ntage percentages that the goods midityMinimum Storage and nformatio should be stored in Handling Low nModule Value Unit of LOGI CAL Data Pool to default Measure SPL POPULATION on outbound Name Logical of message Storage and PERCENT from the Handling Unit population of any of Measure value in storageHandlingHu midityMaximum and or storageHandlingHu midityMinimum Storage and AVP transportationEnvironm Float The maximum atmospheric AVP transportationEnviro Handling entAtmosphericPressMa pressure in which the item transportationEnvir nmentAtmosphericP Type x should be transported to onmentAtmospheri ressureMaximum remain usable This value is cPressureMaximum transportationEnviro the value above which the nmentAtmosphericP trade item should not be ressureMinimum subjected Storage and AVP transportationEnvironm Float The minimum atmospheri
58. are HIBC ICCBBA FDA_NDC_10 and FDA_NDC_11 The population of one of these additionalTradel teml dentificatonTypeCode values will denote the appropriate issuing agency code value for GUDID Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 165 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline This value is paired with the GDSN attribute additionalTradelteml dentificationTypeCode Where this attribute is populated with a value of HIBC ICCBBA FDA_NDC_10 and FDA_NDC_11 then the associated value populated in additionalTradelteml dentification will be provided to the GUDID as the Secondary DI Number This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number DM DI Number and FDA Listing Number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 6 20 Package DI Number FDA GUDID Description A device identifier for the package configuration that contains multiple units of the base package does not include shipping containers Data Entry Notes Edit Rules After Grace Period Enter P
59. as ilisationCode attribute extendedlnitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialManufacturerSter MICROWAVE_RADIATION This is a code value for population with the AVP Packaged as ilisationCode attribute extendedlnitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 100 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Device TRUE initialManufacturerSter AUTOCLAVE Autoclave Steam is a method of sterilisation that Packaged as ilisationCode utilises pressure and heat to achieve a sterile Sterile environment Device TRUE initialManufacturerSter NITROGEN_DI OXIDE This is a code value for population with the AVP Packaged as ilisationCode attribute extendedlnitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialManufacturerSter OZONE Is a method often times used in industrial settings Packaged as ilisationCode to sterilize water and air as well as a disinfectant Steri
60. attributes using this group of attributes are Version or Model Secondary DI Number DM DI Number and FDA Listing Number Device Description FDA GUDID Description Additional relevant information about the device that is not already captured as a distinct GUDID data attribute Device description should include any description found on the device label to support user comparison of the device label to the GUDID device record Otherwise include any additional description or text found in the device labeling Edit Rules After Grace Add Addition of new data is allowed Period Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional Data Type amp Length Type Alphanum Entry List of Values LOV NA Length 2000 New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role additionalTradeltemDescription Datatype Secondary Class Description500 Free Text 1 500 Characters Language Qualified Multiplicity Optional Occurrence Single Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 157 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module TradeltemDescriptionModule Definition Additional variants necessary to communicate to the industry to help define the product Multiple variants can be established for each GTIN This is a re
61. attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Catalog Number Secondary DI Number and FDA Listing Number Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 163 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 18 Issuing Agency FDA GUDID Description Name of Secondary DI Issuing agency Data Entry Notes Choose a value from the drop down LOV Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Optional Data Type amp Length N A Entry List of Values LOV GS1 HIBCC CCBBA NDC NHRIC New DI Trigger NO Public Private Status Public GS1 GDSN Module AdditionalkeyDataTypes Content Attribute Attribute Role additionalTradelteml dentificationTypeCode Datatype Secondary Class Code Multiplicity Mandatory If module is invoked Occurrence Single Definition This code will be used to cross reference the Vendors internal trade item number to the GTIN in a one to one relationship Code List Name AdditionalTradeltemldentificationTypeCode HIBCC ICCBBA FDA_NDC_10 FDA_NDC_11 Population Guidance below The GS1 General Specifications stipulate that a Trade Item can only have one GTIN As the GTIN is the primary DI for an item using GDSN to provid
62. be deployed into the GDSN Schema in 2016 17 into a final solution This Boolean attribute is used to denote if an item is such that is does not require a pre market authorization from the FDA termed an exemption A value of TRUE for this GDSN attribute signifies that the item has been deemed exempt from needing this type of review A value of FALSE or a NULL value will signify that an authorization is required for the item Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 6 32 FDA Premarket Submission Number FDA GUDID Description Number associated with the regulatory decision regarding the applicant s legal right to market a medical device for the following submission types 510 k PMA PDP HDE BLA and NDA Data Entry Notes Enter current FDA Premarket Submission Number s Each DI record represents a version or model of a device For each DI record you must submit the original premarket authorization number and the supplement number through which you obtained approval or clearance for the version or model identified in the DI record as required by 830 310 b 11 FDA Premarket Numbers should be verified with the FDA PMA or 510 k database to make sure the Number represents the subject of the device record Device records sh
63. entered data is allowed s of DUNS info will be permitted Required Required Data Type amp Length NA Entry List of Values LOV Labeler DUNS LOV New DI Trigger NO Public Private Status Private Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 29 of 218 Data Element Description Data Entry Notes Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Public Private Status Company Company name associated with the Auto populated based NA data element is Auto NA NA N A Public Name labeler DUNS Number entered in the on the Labeler DUNS not able to be changed Populated DI Record Number directly most are auto populated fields The labeler company whose information name submitted to depends on another the GUDID should data element match the company name on the device label Company Company physical address Auto populated based NA data element is Auto NA NA N A Private Physical associated with the labeler DUNS on the Labeler DUNS not able to be changed Populated Address Number entered in the DI Record Number directly most are Ideally this address should match the labeler address as shown on the devi
64. equal to one tenth of a metre Size Units of height width depth Measure Pore and netContent Size UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure Pore and netContent Size UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure Pore and netContent Size UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height width depth International System of Units SI Measure Pore and netContent Size UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure Pore and netContent Size UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure Pore and netContent Size UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of Measure Pore Size height width depth and netContent negative 12th power Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 130 of 218
65. healthcare trade item is not safe to safety use in an MRI system information does the labeling contain Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 107 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition What MRI MR Conditional mRICompatibilityCode MRI_COMPATI BLE Indicates that a healthcare trade item is safe to safety use in the presence of a Magnetic Resonance information Imaging MRI System does the labeling contain What MRI Labeling does not mRICompatibilityCode UNSPECIFIED The manufacturer of the Trade Item has not safety contain MRI Safety communicated information on the compatibility of information Information this trade item with a Magnetic Resonance Imaging does the MRI System labeling contain Device labeled TRUE packagingMarkedFreeF FREE_FROM_LATEX The item is physically marked being free from as Not made with natural rubber latex romCode Latex rubber as approved by the appropriate authority of the target market Package Type Intermediate bulk packagingTypeCode AA Intermediate bulk A Rigid Intermediate Bulk Container RIBC that is container rigid plastic container rigid attached to a pallet or has the pallet i
66. humidity and atmospheric pressure SPL Definition Indicates storage requirements are required for the device including temperature humidity etc Choose a value from the drop down LOV Conditions of the Storage and Handling Type are measured below as a range with a Low Value and a High Value More than one Storage and Handling Type can be added per device record Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Optional NA Handling Environment Atmospheric Pressure Handling Environment Humidity Handling Environment Temperature Special Storage Conditions Storage Environment Atmospheric Pressure Storage Environment Humidity Storage Environment Temperature NO Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 59 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Low Value SPL Name Storag e and Handlin g Low Value Indicates the low value for storage and handling requirements SPL Definition Indicates the low value for storage requirements such as temperature humidity etc Enter a number for Low Value Must enter at least one value Low or High but can enter both Low Value and High Value if needed When Storage and Handling value is
67. in the pack 4061414111111c 2 3061414111111c Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be deleted 6 22 Contains DI Package FDA GUDI D Description The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration Data Entry Notes Choose a value from the drop down LOV Webtool Examples Package DI 201 Carton contains base package DI 101 Package DI 202 Carton contains base package DI 101 Package DI 301 contains lower level Package DI 201 Carton Add Addition of new data is allowed Edit Rules After Grace Period Required Conditionally Required If Package DI is entered Data Type amp Length NA Entry List of Values LOV DI numbers base package and all lower levels of packaging New DI Trigger NO Public Private Status Public GS1 GDSN Module Core Item Content ChildTradeltem Attribute Role ChildGTIN generalization Datatype Secondary Class gtin GDSN Mandatory Multiplicity Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 170 of 218 Core Item Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module Occurrence Multiple Definitio
68. latex will be marked Select checkbox if appropriate Only applicable if the response to Device required to be labeled as containing natural rubber latex or dry natural rubber is No Optional element for labelers who include a statement of latex free on their label or in their labeling FDA finds these statements latex free and does not contain latex to be not scientifically supportable and strongly recommends they not be used in medical product labeling Instead FDA recommends the use of the statement Not made with natural rubber latex It is not assumed that all devices NOT made with natural rubber latex are marked therefore this is an optional element for the labelers who choose to make a statement in the labeling Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Data Type amp Length Optional Type Boolean Entry List of Values LOV Release 2 0 Ratified Oct 2015 NA 2015 GS1 AISBL Page 196 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information Only applicable to devices not subject to the requirements under 21 CFR 8
69. network services and a list of GDSN certified Data Pools http www gs1l org gdsn GUDID Data Requirements The Device Identifier DI is the primary key in the UDI database and will be linked to other product data elements Brand Owners will be responsible for submitting and maintaining their own data in the database The U S FDA Global UDI Database GUDID will not contain the Production Identifiers i e Expiration Date Batch Lot Number Serial Number or others Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 25 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline The core elements are the minimum elements needed to identify a medical device through distribution and use Regional or National UDID may contain additional elements however these additional elements should be kept to a minimum International Medical Device Regulators Forum IMDRF UDI System for Medical Devices The Global Unique Device Identification Database GUDID has a set of attributes for population of information about a medical device These attributes are of various types Boolean Code List Text etc and if it is Required or Not Required The specifics of each attribute varies based upon the information requested by the attribute s definition and the type of device being described The table below provides a list of the GUDID attributes and their particulars as current at the
70. number 1234569 Code List Name SerialNumberLocationCode Population Guidance below This GUDID attribute is a Boolean clarifying how the item is controlled It is not for the population of an actual serial number s Neither the GUDID nor GDSN are used to provide an actual serial numbers s These should be communicated in transactional documents such as packaging shipping and invoice documents A GUDID value of TRUE signifies that the item has as one of its controls a serial number s It also signifies that the manufacture date will be printed on the packaging and in the UDI This GDSN attribute is a code list attribute designating where the serial number can be found on the item or its packaging if present If a value is populated for the GDSN attribute of MARKED_ON_PACKAGING MARKED_ON_PACKAGING_INSERT UNSPECIFIED or MARKED_ON_TRADE_ITEM it signifies that the item has as one of its controls a serial number and a value of TRUE will populated for the GUDID attribute It also signifies that the serial number will be printed on the packaging the device and be contained in the UDI Any other code value published in GDSN will populate a value of FALSE for the GUDID attribute Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 193 of 218 6 44 By Expiration Date FDA GUDID Description Indicates the device is managed by expiration date the date by which the label of a d
71. points of Storage eratureMinimum water exactly 180 degrees apart Environment UoM Atmospheric transportationMaximu Pressure mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a and Handling Celsius eratureMaximum temperature scale the freezing point of water is O Units of UoM degrees Celsius C and the boiling point 100 C Measure storageHandlingTemp at standard atmospheric pressure placing the Storage eratureMinimum boiling and freezing points of water exactly 100 Environment UoM degrees apart Atmospheric transportationMaximu Pressure mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to 1 273 16 of the absolute temperature of the triple point of water One kelvin degree is equal to one Celsius degree Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 139 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Storage Environment Humidity Fahrenheit eratureMa
72. production or assembly date determined by the manufacturer The date may refer to the trade item itself or to items contained Expiration Date Expiration Date TRUE Expiration Date TRUE Expiration Date Release 2 0 Ratified Oct 2015 tradel temDateOnPack agingTypeCode tradel temDateOnPack agingTypeCode EXPIRATION_DATE BEST_BEFORE_DATE 2015 GS1 AISBL The expiration date is the date that determines the limit of consumption or use of a product Its meaning is determined based on the trade item context e g for food the date will indicate the possibility of a direct health risk resulting from use of the product after the date for pharmaceutical products it will indicate the possibility of an indirect health risk resulting from the ineffectiveness of the product after the date It is often referred to as use by date or maximum durability date The best before date indicates the ideal consumption or best effective use date of a product It is a statement about quality It is often referred to as a Sell by date or a minimum durability date Page 117 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Unit of Measure Celsius temper
73. structure GS1 Numeric Num with 14 digits HI BCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required If device is subject to 801 45 and DM DI Different from Primary DI is checked Data Type amp Length Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role directPartMarking Datatype Secondary Class String Multiplicity Optional Occurrence Multiple Definition This is a number or marking placed directly on the medical device Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 162 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Code List Name N A GS1 GDSN GS1 GDSN Final Deployment requires 2 GDSN attribute to denote the GUDID DM DI Number Module AdditionalkKeyDataTypes Content Attribute Attribute Role additionalTradelteml dentificationTypeCode Datatype Secondary Class Code Multiplicity Mandatory If module is invok
74. the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GDSN v2 8 Attribute Name FDA GUDID Module Content Attribute Role Datatype Definition GDSN Notes Data Element Secondary Class FDA Tradeltem Attribute additionalTradeltemCla AdditionalTradelte Category code based on Populate with the Premarket Classificati ssificationCode mClassificationCod alternate classification FDA Premarket Submission on e schema chosen in addition to Submission Number the Global Product Number If there Classification GPC is a Supplement Number place a colon after the Premarket Submission Number then add the Submission Number Repeat these attributes and process for all applicable FDA Premarket Submission Numbers and Supplement Numbers additionalClassificati onCategoryCode Supplement If there is a Number Supplement Number place a colon after the Premarket Submission Number then add the Submission Number Repeat these attributes and process for all applicable FDA Premarket Submission Numbers and Supplement Numbers FDA Product Code See FDA Premarket Submission Number Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 76 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class D
75. the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Temperature will be provided To provide Humidity information to the GUDID the GDSN attribute humidityQualifierCode is in a repeatable group of attributes which include minimumHumidityPercentage and maximumHumidityPercentage Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Humidity will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Humidity will be provided The GDSN attributes correlating to the GUDID attributes for atmospheric pressure are temporary attributes AVP in GDSN They will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attributes are in two pairs One pair is for the GUDID storage pressure attributes storageEnvironmentAtmosphericPressureMinimum and storageEnvironmentAtmosphericPressureMaximum The other pair is for the GUDID transportation pressure transportationEnvironmentAtmosphericPressMin and transportationEnvironmentAtmosphericPressMax The applicable storage type can be derived from the attribute name The value provided for the GUDID Unit of Measure will be based on several different GDSN attributes For temperatures the value provided in the GDSN attribute temperatureMesurementUnitCode will be mapp
76. the particular UDI database The GDSN provides a means for any Brand Owner of any size to provide data to all UDI databases and their customers hospitals distributors wholesalers GPOs simultaneously with a single connection Below are the high level steps of the data flow from the Brand Owner to the GUDID when using a GDSN Data Pool 1 The Brand Owner prepares data required by the U S FDA s Global UDI Database 2 The Brand Owner provides GUDID data to their GDSN Source Data Pool of choice 3 The GDSN Source Data Pool converts the data provided by the Brand Owner to the HL7 SPL format refer to the GUDID User Manual for information 4 The GDSN Source Data Pool registers the Brand Owner s product data using the HL7 SPL format in the GUDID 5 The GDSN Source Data Pool confirms the registration with the Brand Owner once a confirmation from the GUDID is received by the GDSN Source Data Pool GDSN Data Pools offer a secure and easy way for Brand Owners to register their product data with any UDI database anywhere in the world via a single connection From a GDSN point of view this type of service is classified as an Out of Network service since the data flow described above is different from the GDSN message choreography This also means that it is not regulated by the Global Registry Access and License Agreement GRALA nor covered by the GDSN Certification Criteria Refer to the GDSN website for more information in and out of
77. the regulation Additional information and specifications on the selection and use of GS1 Data Carriers can be found in the GS1 General Specifications and GS1 UDI support materials http www gs1 org healthcare udi For additional information on identification of items below the each level refer to the GS1 Healthcare GTIN Allocation Rules http www gs1l org 1 gtinrules index php p static t healthcare The role of Global Location Number GLN in UDI The Global Location Number is a 13 digit numeric GS1 standard used to identify locations and legal entities While the U S FDA UDI regulation does not require the use of GLNs in order to comply with the rule it is required when using the Global Data Synchronisation Network GDSN to identify the Brand Owner and the data recipients In addition the U S FDA Global UDI database can be identified by GLN 1100001017041 for GDSN Data Pools who wish to provide this service to their customers This unique identification ensures that there is a single and unique global identification of the U S FDA GUDID within the GDSN Data Pools offering submission and registration of the Brand Owner s medical device product data GDSN Knowledge This guide and the information contained within it require the reader to have a basic understanding of the Global Data Synchronisation Network GDSN For more information on the GDSN refer to the GDSN page on the GS1 website or contact a GS1 member Organisation or a
78. time of the creation of this document as provided by the FDA GUDID Guidance documents While every effort is made to keep this document up to date the official list of attributes and particulars is the responsibility and jurisdiction of the FDA A website link to the official list is provided in the reference section of this document Users of this document are encouraged to review and become familiar with the official list of attributes and particulars as listed on the FDA s websites The table uses the headers as defined below Figure 3 1 FDA GUDID Table legend Header Definition Data Element The name of the element being requested Description Data Entry Notes Text defining the element How the is entry to be accomplished The primary focus of the guidance is primarily written with a web interface user in mind For a machine to machine user the notes will have different meaning and be described in the guidance later in this document Edit Editing of entered data is allowed Rules after Grace Period Once published on the FDA GUDID public facing website for the first time the user will have a 7 day grace period within which changes can be made This field states what editing can be accomplished after the grace period expires Required in Database Is this data element required to be populated by the FDA 0 in the first position signifies not required 1 in the first position signifies required after 2 pe
79. to be used by patients and consumers for device related questions Data Entry Notes Enter phone number For North American numbers type 10 digit number with or without punctuation For international numbers start with and type number without punctuation This phone number could be the 1 800 number that appears on the device labeling or the company website Labelers can identify a Customer Contact phone number and Customer Contact email address for each device record If an email is entered and you don t have a Customer Contact phone number please enter 9999999999 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 174 of 218 Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Phone number for the customer contact to be used by patients and Edit Rules After Grace Period consumers for device related questions Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required ONLY required if Customer Contact Phone is entered Data Type amp Length Type Num Length 10 North American numbers 20 all others Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN requires 3 GDSN attributes to denote the GUDID Customer Contact Phone Content Attribute Attribute Role con
80. to use the GS1 system The GS1 website lists 10 basic steps to barcode implementation and is offered as a guide for getting started For additional information regarding your GS1 Company Prefix and GS1 standards contact your local GS1 Member Organisation by visiting the GS1 website Role of the Global Trade Item Number GTIN and Application Identifiers Als The Global Trade Item Number GTIN as the GS1 trade item Identification Key is used to identify medical devices identifying different product variants and each package configuration to achieve unique and unambiguous identification The UDI includes at a minimum the static portion a Device Identifier DI as its key to specific device related information stored in a database The GTIN is the GS1 solution for creating the Device Identifier component of a UDI and accessing medical device information stored in a database The Unique Device Identifier also includes a dynamic portion known as the Production Identifier to represent production control information generated as part of the manufacturing process based upon the specific medical device This Production Identifier PI can include for example manufacturing date expiry date lot number or serial number GS1 Application Identifiers Als are the GS1 solution for creating the Production Identifier component of a UDI Note the Production Identifier portion of a UDI is NOT stored in a UDI data
81. unit of length in the Size Units of height width depth International System of Units SI Measure and netContent Length UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Length UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Length UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Length Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 125 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure and netContent Length UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height
82. users to understand higher level packaging configurations Data Entry Notes Enter name or description of package This field is free text There is no implied definition or standard quantity to any package name Edit Rules After Grace Period Add Addition of new data is allowed Required Optional Data Type amp Length Type Alphanum Entry List of Values LOV N A New DI Trigger NO Public Private Status Private GS1 GDSN Content Attribute Attribute Role packagingTypeCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition The dominant means used to transport store handle or display the trade item as defined by the data source This packaging is not used to describe any manufacturing process Data recipients can use this data for e Space Planning Data Accuracy Tolerances Supply Chain processes Recycling process In combination with packaging materials Product buying procurement decisions Tax calculations fees duties calculation Code List Name PackageTypeCode Population Guidance below The GDSN attribute is a code list and is mapped to the values needed for the GUDID In GDSN the packaging type code is a 3 character code to identify the type of packaging used for the globalTradeltemNumber In this case this value refers to the globalTradeltemNumber which is being used to populate the GUDID Package DI Number The GUDID is askin
83. waged E N E E Gee 158 6 13 Commercial Distribution End Date s ssssssrssersrrerrtrtrsrrtratttt ernt tt nern trar tn ntre tnanennrne rE nnEn enn 159 6 14 Commercial Distribution Status rnern t tant rn rur EA ntre ERNER tees ee REE NEnn 160 6 15 Device Subject to Direct Marking DM but Exempt cc cece cece cette eee ee eee eee tees ee ea ean 160 6 16 DPM DI Different from Primary DI ener te nena ee EEEE 161 6 17 DPM DI NUMDE kicarrini rinane Or EEEE EET EEO REI AAE PARAE EA NEOR N 162 68 SSUM AJEN EV inai EE EEEE AEE EEE ENa EEES 164 6 19 Secondary DI NUMDEeP s iiicsdciesdere oun or EEN EnEn SEDERE ERE EEEE ERIRE de eckawda ria NENIA 165 6 20 Package DI NuMbDef risana aaora Aa nE EEE EE EEEn case AREA EEES 166 6 21 Quantity per Package er ersni nrerin anaE E E AARONI EEEE ea aad need ESTEPE TEPEDEN RESSE 168 6 22 Contains DI Packages eirian eA RAE ER EE EEEn 170 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 16 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline 6 23 Package TY Pe merino reir rE NE EEEO PNAS TU EDE NEEN E OTENE EET OEE EE EEEN NEDERIGE SEE 172 6 24 Package Discontinue Date 0 renter ne nena nena REENEN 173 6 25 Package Status cisnnipceoresieipeetnieair ss Cael E obigetled viedo as iem xis cane en tiene teens 174 6 26 Customer Contact Phone isis ciiiuceiidisaeeiiieapedidsie aera eee aca eras 174 6 27
84. width depth 0 3048 meters Measure and netContent Lumen Inner Diameter UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimeters Measure and netContent Lumen Inner Diameter UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Lumen Inner Diameter UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Lumen Inner Diameter UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Lumen Inner Diameter UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure and netContent Lumen Inner Diameter Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 126 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name
85. will be printed on the packaging and be contained in the UDI 6 42 Manufacture Date FDA GUDID Description Indicates the device is managed by date of manufacture the date a specific device was manufactured Data Entry Notes Choose Yes No from the drop down list Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role tradeltemDateOnPackagingTypeCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Indicates the type of date marked on the packaging for example Best Before Date Code List Name TradeltemDateOnPackagingT ypeCode Population Guidance below This GUDID attribute is a Boolean clarifying how the item is controlled It will be mapped from the code value PRODUCTION_DATE in the GDSN attribute tradel temDateOnPackagingTypeCode This attribute is not for the population of actual manufacturing dates Neither the GUDID nor GDSN are used to provide actual manufacturing dates These should be communicated in transactional documents such as packaging shipping and invoice documents Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 192 of 218
86. 01 437 Not all medical products that are NOT made with natural rubber latex will be marked New DI Trigger NO Public Private Status Public GS1 GDSN Module HealthWellnessPackagingMarkingModule Content Attribute Attribute Role packagingMarkedFreeFromCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition Indication of the food ingredients that the package is marked free from Code List Name PackagingMarkedFreeFromCode FREE_FROM_LATEX 6 48 Population Guidance below This GDSN attribute is a code list of values representing markings on the packaging The markings signify the device is Free from certain ingredients irritants or allergens This GDSN attribute is only populated to signify what is called out in one of these markings The device might be free from one or more of the ingredients signified by a code value in the code list However the actual code value is only populated here if there is an actual mark on the package calling out the ingredient is not present If a value of FREE_FROM_LATEX is published in the GDSN attribute packagingMarkedFreeFromCode a value of TRUE will be populated in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8
87. 23 UDI and issuing agency information here as barcode from a Secondary DI defined more than one by Issuing issuing agency Data type and field length are Agency for regulatory determined by the individual Issuing structure or marketing Agency structure reasons you must choose GS1 Numeric Num with 14 digits one issuing HIBCC Alphanumeric Alphanum agency with 6 23 characters system as the ICCBBA Alphanumeric with 10 or Primary DI 16 characters and enter the other issuing agency information here as a Secondary DI Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 37 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Data Description Data Entry Notes Edit Editing of entered Required Data Type Entry List of New DI Public Element data is allowed Rules amp Length Values LOV Trigger Private after Grace Period Status with 10 or 16 characters Package Every device package shall bear a UDI 21 CFR 801 20 a 2 Package DIs do not need their own DI record instead package information should be entered in the DI Package DI section of the Primary DI record for that device According t
88. 369258 004 For example a device has a FDA Premarket Submission Number of P147025 Over time 2 Supplements have been filed and approved 001 002 Then a second FDA Premarket Submission Number was obtained P963074 and a subsequent Supplement was filed and approved 001 Population of this information would look like this AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P147025 001 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P147025 002 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P9630074 001 The Data Pool will parse the supplement number from the FDA Premarket Submission Number and provide to the FDA GUDID in the two fields as required by the FDA Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 182 of 218 6 33 Supplement FDA GUDID Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Number assigned by FDA to a supplemental application for approval of a change in a medical device with an approved PMA HDE or PDP Data Entry Notes Enter all valid Supplement Numbers Each DI record represents a version or model of a device For each DI re
89. 5 2015 GS1 AISBL Page 72 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Customer Communic Attribute communicationValue string Text 1 200 Text identifying the endpoint communicationNum Contact ationChan Characters for the communication ber Phone nel channel for example a telephone number or an e mail address Customer Communic Attribute communicationChannel Code Code specifying the type of Value populated for communicationChan Contact Email ationChan Code communication channel for the support contact nelCode nel example TELEPHONE email is EMAIL Customer Communic Attribute communicationValue string Text 1 200 Text identifying the endpoint communicationNum Contact Email ationChan Characters for the communication ber nel channel for example a telephone number or an e mail address Device Status Human Cell AVP doesTradel temContain Boolean The trade item has as a AVP doesTradeltemCont Tissue or HumantTissue component or ingredient doesTradeltemCon ainHumanTissue Cellular or human tissue The amount tainHumanTissue Tissue Based of tissue is not limited to a Product certain amount any amount HCT P will cause a flag of TRUE Kit AVP groupedProduct Code Code representing if the AVP
90. 8 this attribute can be added but can not be edited or deleted Product Code FDA GUDID Description Classification for devices issued by the FDA Data Entry Notes Enter all applicable Product Codes three letter code Edit Rules After Grace Period Add Addition of new data is allowed For all PMA and 510k devices Product Codes are assigned in the FDA approval or clearance letter respectively For Class and exempt devices the device Product Code may be self identified Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 184 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description Classification for devices issued by the FDA Required Conditionally Required Unless device is a kit or IVD with a BL premarket submission number Data Type amp Length Type Alpha Legnth3 Entry List of Values LOV FDA Product Code list New DI Trigger NO Public Private Status Public GS1 GDSN requires 2 GDSN attributes to denote the GUDID Product Code Module GDSNTradeltemClassification Content Attribute Attribute Role AdditionalTradel temClassificationS ystemCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition The Classification System for the Additional Trade Item Classification Code
91. Attribute Is the device labeled for MRI Safety Is no longer supported in the SP Added a column to denote the SPL XPath for the attribute Throughout document where the SPL Information is different from the GUDID Web Guideline document the SPL information has been added in red text If the either document is amended to match the other the extra text will be removed The following are specific changes made Updated the GUDID Data Element field with the SPL Name for Support Contact Phone Support Contact Email Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Size Type Text Storage and Handling Type High Value Low Value Unit of Measure Updated the GUDID Definition field with SPL Definition for Labeler DUNS Number Secondary DI Number Contains DI Package Support Contact Phone Support Contact Email Device Exempt from Premarket Submission Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code Lot or Batch Number Manufacturing Date Serial Number Expiration Date Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 Device labeled as Not made with natural rubber latex MRI Safety Status Size Unit of Measure Storage and Handling Type High Value Low Value Unit of Measure Special Storage Conditions Updated the GUDID Requ
92. B database having a unique separate and distinct operation for the purpose of identifying them A DUNS number is also a way in which separate corporate entities having no official relationship can be branded as one by sharing one DUNS number among the affiliated companies Labeler DUNS additionalPartyl dentifi DUNS_PLUS_FOUR DUNS 4 The DUNS 4 refers to the DUNS number assigned Number cationTypeCode by Dun and Bradstreet plus a 4 character suffix that is assigned by the vendor to establish additional Central Contractor Registration CCR database records for identifying alternative electronic funds transfer EFT accounts for the same vendor located at the same physical address Dun and Bradstreet has no affiliation with the 4 character suffix Code SPL additionalTradel temCl 35 GMDN Global Medical Devices Nomenclature GMDN GMDN Preferred assificationCode Term Code Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 92 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition FDA Premarket Submission Number additionalTradel temCl assificationCode 58 FDA Premarket Submission Number FDA Premarket Submission Number is a number associated with the regulatory decis
93. BI NATION single item such as a kit combination item 6 30 Population Guidance below This attribute has a temporary attribute AVP in GDSN groupedProduct It will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attribute groupedProduct is a code list attribute It is used to specify if an item is a kit or a combination product A value populated for the GDSN attribute groupedProduct of KIT or KIT_AND_COMBINATION will populate a value of TRUE for the GUDID attribute Kit Any other value or when no value is provided for the GDSN attribute will populate a value of FALSE for the GUDID attribute Kit This attribute will be used to provide several sets of information and as such may be repeated GUDID attributes using this attribute are Kit and Combination Products Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Combination Product FDA GUDID Description Indicates that the product is comprised of two or more regulated products Data Entry Notes Check box if DI record is for the combination product itself Do not check that are physically chemically or otherwise combined or mixed and produced as a single entity packaged together as a single package or packaged separately for
94. BL Page 203 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Definition When the clinicalSizeType is coded as DEVICE_SIZE_TEXT_SPECIFY this is the text used to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user Code List Name 6 55 Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeType It will be deployed into the GDSN Schema in 2016 17 into a final solution All of the clinical attributes can be repeated as a group when this value changes In the temporary solution the attribute names end in the numbers 1 2 3 and 4 All of the attributes ending in the same number are in a group together and relate to each other This numbering will be removed in the final GDSN solution This attribute provides a value for this attribute when the GDSN attribute clinicalSizeType is required to be populated when a value of OTHER or DEVICE_SIZE_TEXT SPECIFY is published in the GDSN attribute clinicalSizeType This is free text field and should only be used if the clinical size cannot be specified using specific values in the Clinical Size Type Code List This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7 day
95. Brand Owner must convert their internal data record into the HL7 SPL standard 3 GDSN certified Data Pools can register data on behalf of the Brand Owners using the HL7 Structured Product Labelling SPL standard The Brand Owner will need to list their GDSN Data Pool as their Third Party Data Provider when they create their Labeler profile with the FDA The information is entered into the Data Source s normal GDSN upload or registration interface and marked as applicable to be sent to the FDA GUDID Their GDSN Data Pool would map the appropriate information from the GDSN message into FDA GUDID format and submit on behalf of the data source The GDSN message would also be published to any other data recipients through GDSN as identified via normal the GDSN process GS1 successfully tested this capability with 8 Brand Owners with the support of 1Worldsync and GHX in 2012 during the FDA s user acceptance testing This option is being utilised by many Brand Owners today Figure 2 1 Web based tool ishg lt gt Global UDI DELELE Bulk HL7 SPL eooo GDSN ea A oe For additional information and supporting information refer to the U S FDA GUDID website http www fda gov MedicalDevices DeviceRegulationandGuidance UniqueDevicel dentification Globa IUDI DatabaseGUDI D default htm The GDSN is an Internet based interconnected network of interoperable data pools and a Global Registry the GS1 Glob
96. Customer Contact EMail cece cee EERE EEE DEERE EEE EEE EEE a Eiaeai 176 6 28 Human Cell Tissue or Cellular or Tissue Based Product HCT P c ccceeeeeeeeeee ee ee ee eeeaenens 177 6 29 RC ricer Br cei tes Senger snc osteo dees ol vedere E ie wetness peated toners enact 178 6 30 Combination ProduGt siss knra ea tanraneser sali autgemaxaal enti asa AEE REN ENOR Rea aeaiia 179 6 31 Device Exempt from Premarket Authorization cece eee eee 180 6 32 FDA Premarket Submission NUMDET ccccc eee e eee eee eee ttrt rttr ttnt rnnt rrtt EAR REEE EEEE ERREA Ea EE EES 181 6 33 SUPPIEMOENtH as aieastdeiis re arenino Andie ain n na dian un Ee RA ine N iE TEREPRE com 183 6 34 Product COG mirigna converte NNE E EE ONAA aiauga cnvewigaeasaarauhuren tagayaanams tanta 184 6 35 Product Coge NaMe asinsi aanre E E ENEA A evi eval AEE EEE AN EON ERN 185 6 36 FDA Listing N UMBefiseris irorun E E O E ea a a E Eaa 186 6 37 Code SPL Name GMDN Preferred Term Code and FDA Preferred Term Code scnicccceecrr 187 6 58 Name sirrane E E E A E E es E E T ORA 189 6 39 De finitOM eian a E E A A A A A AT 189 6 40 FOr Single US Enns A E AT E E 190 6 41 Lotor Batch NUMbEM sisi sisecdesdaicievieiscineies eae t ter A E ENA a 191 6 42 Manufacture Date sii ccciiy aces nonini usnu irkinin ik Tn KARAN AARS E LAAEN uae thse a EKETA KEREDE TAR ESS oie 192 6 43 Serial NUMDER si cisiaacshaadiaisiinduad aa a a a Aa A A Aa 193 6 44 By Expiration Dateien a a
97. D Implementation Guideline FDA GUDID Module Content Attribute Role Datatype Definition GDSN Notes GDSN v2 8 Attribute Data Element Secondary Class Name Requires _ LOGICAL Data Pool to default Sterilization POPULATION on outbound Prior to Use Logical BOOLEAN message value of TRUE from the population of any value in initialSterilisationPr iorToUse Sterilization MedicalDe Attribute initialSterilisationPriorT Code This is an indication of the initialSterilisationPri Method viceTradel oUseCode type s of sterilisation that is orToUse temModul required to be completed by e a healthcare provider prior to initial use of the healthcare trade item Sterilisation refers to any process that effectively kills or eliminates transmissible agent Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 90 of 218 FDA GUDID Mapping to GS1 Code Values Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline The list below are FDA GUDID code values mapped to GS1 GDSN Code values For some of these attributes there may be additional code values available for use in GDSN not listed This list focuses on just the values applicable to the GUDID mapping Where the terming PENDING is utilised it means actual code values have either not been identified by the FDA or that a code is in process with the Global Standards Management Process GSMP but not yet as
98. DI Trigger Public Private Status Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA Product Code Product Classification for devices issued by Enter all applicable Add Addition of new Conditional Type FDA Product NO Public Code the FDA Product Codes three data is allowed ly Alpha Code list letter code Delete Deletion of Required For all PMA and 510k entered data is Length 3 devices Product allowed Unless Codes are assigned in Edit Editing of entered device is a the FDA approval or data is allowed kit or IVD clearance letter with a BL respectively For premarket Class and exempt submission devices the device number Product Code may be self identified Product Name associated with the three Auto populated based NA data element is Auto NA NA NO Public Code letter Product Code on 3 letter Product not able to be changed f Populate Name Code directly most are auto populated fields d whose information depends on another data element FDA Listing Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 48 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Data Description Data Entry Notes Edit Editing of entered Required Data Type Entry List of New DI Public Element data is allowed Rules amp
99. DeclaredReusabilityTypeCode the GUDID will be populated with a value of TRUE signifying the device is intended for one use or multiple uses on a single patient For all other values populated in the GDSN attribute manufacturerDeclaredReusabilityTypeCode the GUDID will be populated with a value of FALSE signifying the device can be used more than one time on multiple patients Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited 6 41 Lot or Batch Number FDA GUDID Description Indicates the device is managed by lot or batch number This number can be found on the device label or packaging Lot or Batch means one finished device or more that consist of a single type model class size composition or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits Data Entry Notes Choose Yes No from the drop down list For stand alone software select Yes to indicate that the software version number will be represented as a Lot or Batch number Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Requ
100. Device required to be labeled as containing natural rubber latex or dry natural rubber is No Optional element for labelers who include a statement of latex free on their label or in their labeling FDA finds these statements latex free and does not contain latex to be not scientifically supportable and strongly recommends they not be used in medical product labeling Instead FDA recommends the use of the statement Not made with natural rubber latex It is not assumed that all devices NOT made with natural rubber latex are marked therefore this is an optional element for the labelers who choose to make a statement in the labeling Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional If no data is provided No is stored Data Type amp Length Type Boolean Entry List of Values LOV NA New DI Trigger NO Public Private Status Public Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 54 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Data Description Data Entry Notes Edit Editing of entered
101. E E a A a pee s 194 6 45 Donation Identification NUMDES ccc ne rnnr tnn REED EEE EE EEE EGE EA EEE EEE EES 194 6 46 Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 arerin E E ENE A E AE ONTE aie wide ees eae 195 6 47 Device labeled as Not made with natural rubber latex 0c ee eect ee eee eee ee ea ena 196 6 48 Prescription Use RX iisiisdicscisaccisdiasceisiana sls aaa a and ninsoe Mead aa Leananals 197 6 49 Over the Counter OTC cccccccccccececsceee eects eeeeeeeee sees sees eget seen eeeteeeeeseeeseeeveueegetenentsgenegannyes 198 6 50 What MRI safety information does the labeling contain cece eee ee eee ee ee ee ee eaten eae 199 65L SIZET YPC irctseaniearsenns E ATA E date T AT AT niente ane nies 200 6 52 SiZe ValUC tiseisieiininn ciiasina disease oie aend Mas ba pheamanignieamirinnad klaw land Minseu eeeGe aT eeaaNa eS 201 6 53 Size Unit OF MeasSUlei sunrise ioh oina aniar e ar A Einn eae nn Deni 202 6 54 Size Type Text SPL Name Size Text sssssrsrrsrrrrersrrerantrrerntttntrstratttntretnnrensrnerannenenn 203 6 55 Storage and Handling Type siirron apin nianna nene EEN EERE OSRE pened ig eee 204 6 56 Low Value SPL Name Storage and Handling Low Value c ceeeeee eset eect ee ee te ee teen eaeas 207 6 57 High Value SPL Name Storage and Handling High Value cceeeeceeeee eect ee ee ee ee ee eaenens 210 6 58
102. EEE VEE PE EEOrTETENE 21 1 8 Data GOVermnanCes E E E T 22 1 9 Roles and Responsibilities cieri nair birisr orinni eoi nT EN EENEN E IED EE Ur DN PEN EENE 23 GDSN Data F OW sssssssssssnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnnm 2S GUDI D Data Re eguirementsS wisnssissccssccccasnncsencanedsercsmaaanscesnrssecimecsmacenccnmnemncten LO GS1 GDSN to FDA GUDI D Mapping sssssssssseseseeesesesseessssseneeseseeeeeseessees 65 FDA GUDI D Mapping to GS1 Code ValueS ssssssssssunsuusnnnuuunnnnnnnnnnnnnnnnnnnnn OL Guidance on Populating ValueS s sssssssssss55512550555u2u005552uuuuu0nuuunnnnnnnnnnnnnnnn LOZ 6 1 ISSUING AJENCY scstuneoeescaanennietaeeresin eaeaicer coe enna tea deer T O EE 147 6 2 Primary Dlie a E id iaaaa as iain Oe ea a NA R Cees 148 6 3 Device Cl0 0 9 aero eee ree ee ee ee ee ee eee 148 6 4 Unit of Use DIF NUMDEF cossi team teats air n aahs Gee eee es 149 6 5 Labeler DUNS NUMDEf scesccssictegarsereannesapiesenrexanbtasaritaevsertnnensisaetia DEE TRIT DDr RERED 151 6 6 Company NaMe csacsi reiasa a a A ENEE NAA A AAAA AAE REAA EAGT 152 6 7 Company Physical AddreSS icc secsavas nana O A E AE TE E EAE 153 6 8 Brand Name sssdeciescacveves ann nE E O wt ean EE A ea OE 154 6 9 Version or Modelirna a eter activ E ors ETa E E ET AE AE 155 6 10 Catalog N MDepnsircrmocao nopan A E E 156 6 14 Device DESCRIPTION sorin Seanawiecenpanceelwdsicinein O a a TT 157 6 12 DI Record Publish Datemi norra Gas te tae ees date
103. GMDN Code FDA PT Code if necessary Must enter GMDN Code OR FDA PT Code please don t enter both codes for the same GMDN Name and Definition For GMDN Codes Enter only the 5 digit number omit the P For FDA PT Codes Enter the 4 letter code The FDA PT Codes are assigned to each GMDN term used in place of a GMDN Code They enable labelers to assign a GMDN term to their GUDID submission until a GMDN Code can be obtained from the GMDN Agency The FDA PT Codes can be found in the Find FDA PT Code Module on the GUDID website For more information see the GUDID Final Guidance Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Type Num Length 5 NA NO Private Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 50 of 218 Data Element Description Data Entry Notes The FDA PT Codes can be found in the Find FDA PT Code Module on the GUDID website Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Public Private Status SPL Name SPL Text Unique four character SPL Text SPL Text SPL Text FDA value
104. GS1 GDSN Code Group Code Name Code Definition UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic unit of length in the Size Units of height width depth International System of Units SI Measure and netContent Height UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Height UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Height UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Height UoM Length um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure and netContent Height UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height width depth 0 3048 meters Measure and netContent Length UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimet
105. I environment All GDSN code values map to an applicable GUDID code value Whieitis net recommended te use a GDSN value ef UNSPECIHED asthis s cal inf hia hae nai if GDS value UNS PEC FLER is sublishea thse mrappedte MRUasafeas adefautt Release 1 3 1 Draft Release 2 0 Release 2 0 May 2015 Jul 2015 Oct 2015 Disclaimer David Buckley Valerie Hoste David Buckley WR15 183 Update for major release Applied new GS1 branding prior WR15 290 Errata approval of branding at 29 Sep 2015 SMG call GS1 under its IP Policy seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in the Work Group that developed this Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline to agree to grant to GS1 members a royalty free licence or a RAND licence to Necessary Claims as that term is defined in the GS1 IP Policy Furthermore attention is drawn to the possibility that an implementation of one or more features of this Specification may be the subject of a patent or other intellectual property right that does not involve a Necessary Claim Any such patent or other intellectual property right is not subject to the Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 14 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline licencing obligation
106. Length Values LOV Trigger Private after Grace Period Status FDA Number assigned by FDA during Enter all relevant Add Addition of new Conditional Type NA NO Private Listing Registration and Listing to all devices listing numbers that data is allowed ly Alphanum Number in commercial distribution enable the labeler to Required regardless of pre market commercially Length 7 authorization requirements per 21 distribute the given Unless CFR 807 28 f version or model of device is device an HCT P Listing number is kit or IVD optional for HCT P with a BL devices Kits and premarket IVDs with a BLA submission premarket number number GMDN Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 49 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Code SPL Name GMDN Preferred Term Code FDA Preferred Term Code GMDN Preferred Term PT Code is a unique five digit code used to identify common device types This PT Code is assigned to medical devices and related health care products for the purposes of grouping and categorization SPL Definition Unique numerical five digit number used to generically identify medical devices and related health care products Enter all applicable GMDN Preferred Term Codes or FDA PT Codes Each device record must have at least one assigned GMDN Code FDA PT Code DI records are allowed gt 1
107. LevelTradel tem Datatype Secondary Class nonNegative Integer Multiplicity GDSN Dependent Occurrence Single Definition The number of one child trade item as identified by the association of ChildTradeltem class to Tradeltemldentification class contained by the parent trade item The child trade item must be in the hierarchy level immediately below the parent trade item Code List Name N A Population Guidance below The GUDID Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references a GTIN in the hierarchy above the primary DI This would be or is one of the parent s of the primary DI These parents are identified by their own GTIN and GDSN Message They are linked together through the use of the parent child relationship Population of the GUDID values for the package information will be based on any value populated in the GDSN attribute tradeltemUnitDescriptor with the exception of BASE_UNIT_OR_EACH The GTIN with a tradeltemUnitDescriptor value of BASE_UNIT_OR_EACH will always be a Primary DI for the GUDID See th
108. Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 39 of 218 Data Element Quantity per Package Description The number of packages with the same Primary DI or Package DI within a given packaging configuration Data Entry Notes Enter the number of devices per package The quantity of a package configuration must be gt 1 Examples Package Carton Pkg DI 201 contains 4 boxes of DI 101 the quantity per package is 4 Package Case Pkg DI 301 contains 5 cartons of Pkg DI 201 the quantity per package is 5 Package Carton Pkg DI 202 contains 10 boxes of DI 101 the quantity per package is 10 Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Required Conditional ly Required If Package DI is entered Data Type amp Length Type Num Length 9 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Contains DI Package The Primary DI for the base package or the Package DI for any lower level package configuration contained within a given package configuration Choose a value from the drop down LOV Examples Package DI 201 Ca
109. List Name AdditionalTradeltemClassificationCodeListCode 43 Module TradeltemClassification Content Attribute Attribute Role additionalTradeltemClassificationCode Datatype Secondary Class AdditionalTradel temClassificationCode Multiplicity Optional Occurrence Multiple Definition Category code based on alternate classification schema chosen in addition to the Global Product Classification GPC Code List Name N A Population Guidance below This repeatable set of attributes will allow for the population of a FDA Product Code for the device This can be accomplished by the population of the code value 43 in the GDSN attribute AdditionalTradeltemClassificationSystemCode The actual Product Code can then be populated using the associated value in the GDSN attribute additionalTradeltemClassificationCode This set of attributes will also be used to populate several pieces of information FDA Product Code FDA Premarket Submission Number FDA Preferred Term Code and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device 6 35 Product Code Name FDA GUDID Description Name associated with the three letter Product Code Data Entry Notes Auto populated based on 3 letter Product Code Edit Rules After Grace Period NA data element is not able to be changed directly most are auto populated fields whose information depends on another data element
110. M for GUDI D Required and GUDID Occurrence These columns had been repeated from the left side of the spreadsheet as a convenience when the sheet was shifted to view the columns on the right side This was causing issues and the columns are removed as redundant information Updated tab containing the Sterilization Method codes to detail all requested GDSN codes and the FDA value of Liquid Chemical can be aligned with FORMALDEHYDE GLUTERALDEHYDE and ETHANOL Updated Logo to new GS1 US logo Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 8 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline 4 09 May 2014 Release 2 0 Ratified Oct 2015 Scott Brown 2015 GS1 AISBL Updated the following sections 3 4 5 to align document with the release of the FDA GUDID SPL version 1 2 1 issued on April 16 2014 Added validation guidance for MR Safety Status Updated UoM list to group codes for clinical size types highlighted GDSN codes to be removed in the GDSN Major Release and highlights FDA GUDID Codes including GDSN Change Request to add Added tab containing guidance from the FDA on Premarket Submission Number formats Added new attributes for the Donation Identification Number FDA Preferred Term Code including GDSN Change Request to add Noted that the GUDID Attribute Is the device labeled for MRI Safety Is no longer suppor
111. MP Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 2 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline 4 20 May 2014 Scott Brown Updated spelling errors and grammatical errors throughout the document Updated cover header and footer areas to reflect the change in version and that the version is a Draft and still needs IP review and ratification to occur Updated Section 3 page 23 updated the table legend with corrected headers based on the FDA GUDID Guidance document Updated Section 3 page 24 updated a note regarding the FDA GUDID Guidance document and the updating of this document to reflect changes in the FDA Documents Updated Section 3 pages 25 57 listing of attributes with various changes Primarily changing the content from the FDA GUDID Guidance documents such as values for the GUDID of Attribute Name Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length and Entry List of Values LOV values for the GDSN of New Attributes and Guidance There are also various formatting and spelling changes throughout this section All changes are in red text and highlighted in yellow Some changes denote a difference in the FDA GUDID Webtool Guidance and Guidance for the use of HL7 SPL messaging machine connection to the FDA GUDID To aid readability and printabilit
112. N Beta particles are able to penetrate living matter to a certain extent radiation intensity from a small source of radioactive material decreases as one over the distance squared and can change the structure of struck molecules Sterilization Method Radiation initialSterilisationPrior ToUseCode GAMMA_RADIATION Gamma rays are very penetrating and are commonly used for sterilisation of disposable medical equipment such as syringes needles cannulas and IV sets Gamma radiation requires bulky shielding for the safety of the operators they also require storage of a radioisotope usually Cobalt 60 which continuously emits gamma rays it cannot be turned off and therefore always presents a hazard in the area of the facility Sterilization Method Sound Waves initialSterilisationPrior ToUseCode SOUND_WAVES This is a code value for population with the AVP attribute extendedlnitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Method Supercritical Carbon Dioxide initialSterilisationPrior ToUseCode SUPERCRITI CAL_CARBON_ DI OXI DE This is a code value for population with the AVP attribute extendedlnitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 106 of 218 FDA
113. N for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Name Code Definition Code Attribute Code Group Code Group UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Circumference UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Circumference UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Circumference UoM Length um Micrometer clinicalSizeValue Volume 4G Microlitre A microlitre is one millionth of a litre Size Units of height width depth Measure and netContent Circumference UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height width depth 0 3048 meters Measure and netContent Depth UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimeters Measure and netContent Depth UoM
114. ON _REQUIRED is published in the GDSN attribute consumerSalesConditionCode attribute a value of TRUE will be populate in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute 6 49 Over the Counter OTC FDA GUDID Description Indicates that the device does not require a prescription to use and can be purchased over the counter OTC Data Entry Notes Select checkbox if appropriate Can select both Rx and OTC for one DI record Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional If no data is provided No is stored Data Type amp Length Type Boolean Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role consumerSalesConditionCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required Code List Name ConsumerSalesConditionTypeCode OTC Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 198 of 218 6 50 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidan
115. Partyl denti Number KeyDataT ationTypeCode use of a code in addition to is a GDSN ficationType ypes the Global Location Number Mandatory attribute This pair of attributes will be provided as additional party identification tied specifically to the Brand Owner GLN Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 66 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Labeler DUNS PartylnRol Attribute additionalPartyl dentific string Text 1 80 Identification of a party by additionalPartyl denti Number e ation Characters use of a code other than the ficationValue Global Location Number Company FDA will populate Name based on the DUNS and D amp B Company FDA will populate Physical based on the DUNS Address and D amp B Brand Name Tradeltem Attribute brandName string Text 1 70 The recognizable name used brandName Descriptio Characters by a brand owner to uniquely nModule identify a line of trade item or services This is recognizable by the consumer Version or Additional Attribute additionalTradeltemlde Code This code will be used to Use code value of additionalTradel tem Model KeyDataT ntificationTypeCode cross reference the Vendors MODEL_NUMBER I dent
116. T attribute extendedI nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 103 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Sterilization High level Disinfectant initialSterilisationPrior HIGH This is a code value for population with the AVP Method ToUseCode LEVEL_DISINFECTANT attribute extendedl nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Hydrogen Peroxide initialSterilisationPrior HYDROGEN_ PEROXIDE Another chemical sterilizing agent It is relatively Method ToUseCode non toxic once diluted to low concentrations although a dangerous oxidizer at high concentrations and leaves no residue Sterilization Liquid Chemical initialSterilisationPrior ETHANOL A chemical sterilisation method that utilises ethanol Method ToUseCode as the sterilisation method Sterilization Liquid Chemical initialSterilisationPrior FORMALDEHYDE A chemical sterilisation agent used to provide Method ToUseCode sterilisation Items being sterilized are usually immersed in the formaldehyde for a pre dete
117. The guidance and GDSN attributes included in this document is based on the published database requirements and GUDID Users Guide from the U S FDA plus the lessons learnt from the GDSN pilot held as part of the U S FDA User Acceptance testing of 2012 This document contains addition guidance on Master Data Management and Governance plus Information Lifecycle Management and Data Quality This information is intended as general guidance for the purpose of assisting GS1 members The UDI regulation may contain specific information related to the rule which in case of conflict supersedes this general guidance Prerequisite It is assumed that the reader is already familiar with the UDI regulation and the database requirements prior to using this implementation guide For additional information on UDI visit the GS1 UDI webpage or the website of the specific regulation in question Below are a few basics steps the Medical Device Brand Owner should consider prior to using their GDSN Data Pool to register their medical device product data in the appropriate UDI database The section includes prerequisites for using GS1 standards to implement a UDI regulation The GS1 Global Company Prefix GCP The GS1 Global Company Prefix is the base component used to create a GS1 Key such as a Global Trade Item Number GTIN The GS1 Global Company Prefix is a license to create GS1 Keys and is issued by any one of the GS1 Member Organisations to companies who wish
118. Unit of Measure SPL Name Storage and Handling Unit of Measure cecececee cece teeta es 212 6 59 Device Packaged as Sterile cece eee ener te ne ee ee en tn ens 215 6 60 Requires Sterilization Prior to USC 20 0 ene nene es 216 6 61 SteriliZation Method isicdcticnciess eiiaeid Voted How eel bend seidacnr dl iPad rnd nein eens ri neo iid atsd binds 217 7 Referent eS roana aa aaa LO Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 17 of 218 1 1 1 2 1 3 1 3 1 1 3 2 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Introduction Purpose of this Document The purpose of this document is to explain how to leverage the Global Data Synchronization Network GDSN infrastructure to securely provide data to a Unique Device Identification UDI database The first version of this implementation guide will focus on the U S FDA Global Unique Device Identifier Database GUDID requirements since this is the only regulator to issue a UDI rule for medical devices as of this writing As other regulators introduce UDI regulation this document will be updated as needed Who Will Use this Document This document is intended primarily for medical device Brand Owners who have decided to use GS1 standards to comply with UDI regulation and the GDSN Data Pools who will be required by the medical device customers to provide data on their behalf to a UDI database
119. UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling tmosphericPressureM Units of aximum UoM Measure storageEnvironmentA Handling tmosphericPressureMi Environment nimum UoM Atmospheric transportationEnviron Pressure mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Relative Humidity dityMaximum UoM Units of storageHandlingHumi Measure dityMinimum UoM Handling transportationHumidi Environment tyMaximum UoM Atmospheric and Pressure transportationHumidi tyMinimum UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing point of water is 32 degrees Fahrenheit F and the boiling point 212 F at standard atmospheric pressure placing the boiling and freezing points of water exactly 180 degrees apart Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 135 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code G
120. _AND_COMBI NATION Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 doesTradeltemContain Latex FALSE The Brand Owner labeling does not state the Trade Item contains latex or may state that the Trade Item is free from latex Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 doesTradeltemContain Latex TRUE Brand Owner labeling states the Trade Item contains latex Storage and Handling Type Storage Environment Humidity humidityQualifierCode STORAGE_HANDLING Trade Item is being stored or handled Storage and Handling Type Handling Environment Humidity humidityQualifierCode TRANSPORTATION Trade item is in process of being transported in the supply chain Device Packaged as Sterile TRUE initialManufacturerSter ilisationCode CHLORI NE_DIOXIDE This is a code value for population with the AVP attribute extended nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 98 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute Description where Code G
121. _AND_COMBINATION will populate a value of TRUE for the GUDID attribute Kit Any other value or when no value is provided for the GDSN attribute will populate a value of FALSE for the GUDID attribute Combination Product This attribute will be used to provide several sets of information and as such may be repeated GUDID attributes using this attribute are Kit and Combination Products Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Device Exempt from Premarket Authorization FDA GUDID Description Device is exempt from FDA Premarket regulations or a pre amendment Data Entry Notes Edit Rules After Grace Period device Select checkbox if FDA has by regulation exempted this device from premarket submission requirements or for preamendment devices that are not subject to premarket submission requirements If left unselected a No is stored and a Premarket Submission Number should be entered below None NO edit add or delete are allowed Required Conditionally Required Premarket Submission Number OR exempt status fulfills regulatory requirement Data Type amp Length Type Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public Module GS1
122. a range this is the lower end of that range When Storage and Handling value is less than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling High Value Can edit add or delete after Grace Period 00 A Low Value and or a High Value is required if Storage and Handling is provided SPL Text 0 1 Conditional ly Required One value Low or High is required if Storage and Handling Type is added to the device record Numeric 6 N A NO Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 60 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size High Value SPL Name Storag e and Handlin g High Value Unit of Measure SPL Name Storage and Handling Unit of Measure Indicates the high value for storage and handling requirements SPL Definition Indicates the high value for storage requirements such as temperature humidity etc The unit of measure associated with the storage and handling conditions SPL Text The unit of measure associated with the storage and handling conditions The unit of measure associated with the storage and handling conditions The unit of measure associated with the storage and handling conditions Release 2 0 Ratified
123. ackage DI Number Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HI BCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Examples Box of Gloves DI 101 4 Boxes of Gloves DI 101 in a Carton Package DI 201 the UDI on the Carton 5 Cartons Pkg DI 201 in a Case Package DI 301 the UDI on the Case 10 Boxes of Gloves DI 101 in a Carton Package DI 202 the UDI on the Carton Add Addition of new data is allowed Required Data Type amp Length Conditionally Required f device is available in higher levels of packaging Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN requires 2 GDSN attribute to denote the GUDID Package DI Number Module GS1ldentificationComponents Content Attribute Attribute Role gtin Datatype Secondary Class GTIN Multiplicity GDSN Mandatory Occurrence Single Definition Global Trade Item Number GTIN the GS1 key used for the identification of trade items Code List Name N A Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 166 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Core Item Module Con
124. ackage Type Sleeve Release 2 0 Ratified Oct 2015 packagingTypeCode SY 2015 GS1 AISBL Sleeve A non rigid container usually made of paper cardboard or plastic that is open ended and is slid over the contents for protection or presentation Page 115 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Package Type Tube packagingTypeCode TU Tube A cylindrical container sealed on one end that could be closed with a cap or dispenser on the other end Package Type Package Type Wrapper Banded package packagingTypeCode packagingTypeCode WRP X11 Wrapper Banded package The process of enclosing all or part of an item with layers of flexible wrapping material e g for an individually packed ice cream Does not include items which are shrink wrapped or vacuum packed Something used to bind tie or encircle the item or its packaging to secure and maintain unit integrity Package Type Flexible Intermediate Bulk Container packagingTypeCode ZU Flexible Intermediate Bulk Container A non rigid container used for transport and storage of fluids and other bulk materials The construction of the IBC container and the mater
125. acteristics For Single MedicalDe Attribute manufacturerDeclaredR Code Determines if the product is LOGICAL manufacturerDeclar Use viceTradel eusabilityTypeCode intended for single or POPULATION edReusabilityType temModul multiple uses including the Logical BOOLEAN e number of validated cycles value of TRUE from and the number of times a the population of a product can be used value of according to the SINGLE_USE or manufacturer specifications REUSABLE_SAME_ It is suggested that medical PATIENT in providers consult the device manufacturerDecla manufacturer s Instruction redReusabilityType For Use IFU for full all other values reusability instructions equate to a FALSE value Production dentifier s on Label Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 79 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Lot or Batch Number Packaging MarkingM odule Attribute hasBatchNumber Boolean Indication whether the base trade item is batch or lot number requested by law not batch or lot number requested by law but batch or lot number allocated or not batch or lot number allocated A batch or lot number is a manufacturer assigned code used to identify a t
126. adeltemlde AdditionalTradelte Alternative means to the additionalTradeltem change ficationCo ntification mldentification Global Trade Item Number to I dentificationValue mponents identify a trade item GMDN Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 77 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name the Global Product Classification GPC either the GMDN or FDA Code is provided to the GUDID the FDA will derive the actual term from a mapping to the GMDN or FDA Preferred term listing Code SPL GDSNTrad Attribute additionalTradeltemCla Code The Classification System for Use code 35 additionalClassificati GMDN eltemClas ssificationSystemCode the Additional Trade Item onAgencyName Preferred sification Classification Term Code Code SPL Tradeltem Attribute additionalTradeltemCla AdditionalTradelte Category code based on Code value additionalClassificati GMDN Classificati ssificationCode mClassificationCod alternate classification managed by onCategoryCode Preferred on e schema chosen in addition to GMDN FDA Only Term Code the Global Product either the GMDN or Classification GPC FDA Code is provided to the GUDID the FDA will derive the
127. al Distribution automatically by the FDA 6 15 Device Subject to Direct Marking DM but Exempt FDA GUDID Description The device is exempt from Direct Marking requirements under 21 CFR 801 45 Data Entry Notes Select checkbox if appropriate Webtool Labeler should select the checkbox Device Subject to Direct Marking DM but Exempt only if the device 1 is intended to be used more than once and 2 is intended to be reprocessed before each use but also 3 meets any one of the exception criteria outlined under 21 CFR 801 45 d Ifthe device is not required to be directly marked under 21 CFR 801 45 a then this box should not be checked Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required If device is subject to 801 45 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 160 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description The device is exempt from Direct Marking requirements under 21 CFR 801 45 Data Type amp Length Type Boolean Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role isTradeltemExemptFromDirectPartMa
128. al Registry that enables companies around the world to exchange accurate standardised and synchronised supply chain data with their trading partners The Global Data Synchronisation Network GDSN enables Brand Owners distributors and providers to share accurate product information electronically In addition to receiving the initial product data the customer can receive product update notifications automatically from the supplier The GDSN is an attractive option for Brand Owners who also need to provide product master data to providers GPOs and distributors since it allows them to provide the right data to the right party with a single connection as illustrated below Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 24 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Figure 2 2 HOSPITAL PROVIDER BRAND OWNER US FDA GUDID FDA GUDID BRAND OWNER BRAND OWNER RETAILER BRAND OWNER JAPAN GUDID Regulators are working together via the International Medical Device Regulators Forum IMDRF to align as much of their requirements as possible However each regulator will probably have a specific and distinct set of data requirements This means that Brand Owners will need to maintain separate data records for each UDI regulator s database Additionally they will need to establish separate connections or methods of registering their product data in
129. and heat to achieve a sterile environment Sterilization Nitrogen Dioxide initialSterilisationPrior NITROGEN_DI OXIDE This is a code value for population with the AVP Method ToUseCode attribute extendedlnitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Ozone initialSterilisationPrior OZONE Is a method often times used in industrial settings Method ToUseCode to sterilize water and air as well as a disinfectant for surfaces It has the benefit of being able to oxidize most organic matter It is a toxic and unstable gas that must be produced on site so it is not practical to use in many settings Sterilization Peracetic Acid initialSterilisationPrior PERACETIC_ACID A chemical in the organic peroxide family It is a Method ToUseCode bright colorless liquid with a characteristic acrid Release 2 0 Ratified Oct 2015 2015 GS1 AISBL acetic acid type odor It has a strong oxidizing potential is highly corrosive and can explode at temperatures exceeding 110 C Page 105 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Sterilization Method Radiation initialSterilisationPrior ToUseCode BETA_RADI ATIO
130. and will always serve as the point of reference for U S FDA UDI requirements 2 Enrich and Validate This step refers to an internal process by which the data created in step one is completed with any missing data validated for compliance with specific requirements of the UDI regulation and approved This is a fundamental step in data quality management GS1 offers general data quality guidance and best practices based on industry experience including the GS1 Data Quality Protocol Below are a few basic steps to consider Completeness Is data missing which is needed for that specific product o Accuracy Is data precise correct and current Conformity Have formatting rules and standards been applied properly Logic Is data valid or conflicting across product classes Consistency Is data consistent across systems for the same field Integrity Are there appropriate data linkages between internal systems Duplication Are there unnecessary representations of the same data For specific information regarding data quality and validation requirements of the U S Global UDI Database refer to FDA regulation and User Guide 3 Publish and Activate Once the data is created enriched validated and approved it can be published and activated for use Publication can refer to internal users catalogues or the GDSN Source Data Pool for data synchronization with external users In relationsh
131. applicable Definition Device TRUE initialManufacturerSter UNSPCEIFI ED Trade Item Manufacturer has not specified the Packaged as ilisationCode sterilisation method s of the trade item Sterile Sterilization Chlorine Dioxide initialSterilisationPrior CHLORINE_DIOXIDE This is a code value for population with the AVP Method ToUseCode attribute extended nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Dry Heat initialSterilisationPrior DRY_HEAT This is a code value for population with the AVP Method ToUseCode attribute extended nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Ethylene Oxide initialSterilisationPrior ETO_ETHYLENE_OXIDE A gas that is commonly used to sterilize objects Method ToUseCode sensitive to temperatures greater than 60 C such as plastics optics and electrics Ethylene oxide treatment is generally carried out between 30 C and 60 C with relative humidity above 30 and a gas concentration between 200 and 800 mg L for at least three hours Ethylene oxide penetrates well moving through paper cloth and some plastic films and is highly effective Sterilization High Intensity Light or initialSterilisationPrior HIGH_INTENSITY_LIGHT_ This is a code value for population with the AVP Method Pulse Light ToUseCode OR_PULSE_LIGH
132. assigned by the FDA to rar Alpha 4 FDA DB Preferred indicate a GMDN Preferred Term Required Term without exposing the GMDN PT either Code Code GMDN PT Code or FDA PT Code Name Name of the common device type Auto populated based NA data element is Auto NA NA NO Public associated with the GMDN Preferred on GMDN Preferred not able to be changed Populated Term Code FDA PT Code Term Code FDA PT directly most are Code auto populated fields whose information depends on another data element Definition Definition of the common device type Auto populated based NA data element is Auto NA NA NO Public associated with the GMDN Preferred on GMDN Preferred not able to be changed Populated Term Code FDA PT Code Term Code FDA PT directly most are Code auto populated fields whose information depends on another data element Device Characteristics For Choose Yes No from the drop down None NO edit add Required Type Choose Yes No YES Public Single Use list or delete are allowed Boolean Yes No from the drop down list Production dentifier s in UDI Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 51 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Valu
133. atabase GUDID Implementation Guideline Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can only be changed with Dunn and Bradstreet D amp B Many of the data elements are locked and can no longer be edited FDA GUDID Description Data Entry Notes Company Physical Address Company physical address associated with the labeler DUNS Number entered in the DI Record Auto populated based on the Labeler DUNS Number Ideally this address should match the labeler address as shown on the device label but since this data element is not be displayed to the GUDID public user this is not a requirement for data consistency Edit Rules After Grace Period N A data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length N A Entry List of Values LOV N A New DI Trigger N A Public Private Status Private GS1 GDSN Module N A Content N A Attribute Role N A Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance Below The FDA will populate this information into the GUDID based on information from D amp B based on the Labeler DUNS provided If the information is not correct D amp B should be contact
134. atalog Number DM DI Number and FDA Listing Number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 164 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 19 Secondary DI Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period An identifier that is an alternate secondary lookup for a medical device that is issued from a different issuing agency than the primary DI Under 21 CFR 830 40 a only one device identifier from any particular system for the issuance of UDIs may be used to identify a particular version or model of a device Enter Secondary DI Number If your product is labeled with a UDI and barcode from more than one issuing agency for regulatory or marketing reasons you must choose one issuing agency system as the Primary DI and enter the other issuing agency information here as a Secondary DI Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters None NO edit add or delete are allowed Required Da
135. ate a sequence number of a component of a trade item Code List Name Module Core Item Content Attribute Attribute Role componentl dentification Datatype Secondary Class Identifier GTIN Multiplicity Optional Occurrence Single Definition An identifier for a component Code List Name N A Population Guidance below If the Device Count is greater than 1 gt 1 the unit of use DI is required for population in the GUDI D In GDSN Unit of Use Dis are populated as a component of a GTIN The first attribute componentNumber is a sequence number and would not be populated in the FDA GUDID The second attribute componentl dentifier is the GTIN which is assigned to the Unit of Use DI Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 150 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 5 Labeler DUNS Number FDA GUDID Description Business number issued by Dun amp Bradstreet D amp B that is used to associate the Labeler Company name and address to a given version of model of a device in GUDI D Data Entry Notes Choose appropriate DUNS Number from drop down LOV Webtool To ensure data consistency for the GUDI D DUNS number submitted to the GUDID should associate to the company name that appears on the device label ideally the address associated with the DUNS number should also match the address on the device label
136. atex Which May Cause Allergic Reactions 2 This Product Contains Dry Natural Rubber 3 Caution The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions or 4 The Packaging of This Product Contains Dry Natural Rubber Choose Yes No from the drop down list Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Data Type amp Length Required Type Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 195 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Healthcareltem InformationModule Content Attribute Attribute Role doesTradel temContainLatex Datatype Secondary Class NonBinaryLogicEnumeration Multiplicity Optional Occurrence Single Definition An indication that the trade item has a positive latex reference on the Trade Item s labeling Code List Name NonBinaryLogicEnumerationCode 6 47 Description Data Entry Notes Population Guidance below This GDSN attribute is a Non Binary Logic Code List with the values of TRUE FALSE NOT_APPLICABLE and UNSPECIFIED For the US Target Market the only values which can be used are TRUE and FALSE f
137. atureMeasurem CEL Celsius also historically known as oand entUnitCode centigrade is a temperature scale the Handling Unit of freezing point of water is 0 degrees Measure Celsius C and the boiling point 100 C at standard atmospheric pressure placing the boiling and freezing points of water exactly 100 degrees apart Unit of Measure Fahrenheit temperatureMeasurem FAH The Fahrenheit temperature scale the freezing SPL Name Storage and Handling Unit of Measure entUnitCode point of water is 32 degrees Fahrenheit F and the boiling point 212 F at standard atmospheric pressure placing the boiling and freezing points of water exactly 180 degrees apart Figure 5 2 The following are the Unit of Measures UoM which are used by FDA and the corresponding UoM used in GDSN FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Code Name Code Definition UoM Angle Units of Measure Angle UoM Area Units of Measure Area Surface Area UoM Area Units of Measure Area Surface Area deg Degree sft_i Square foot sin_i Square inch netContent netContent netContent GS1 GDSN Code Group Count DD Area FTK Area INK Degree Unit of Angle Square foot Square inch A measurement of plane angle representing 17360 of a full rotation one degree is equivalent to 180 radians A square f
138. base Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 18 of 218 1 3 3 1 3 4 1 3 5 1 4 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Additional information regarding the use of the GS1 GTIN and Application Identifiers can be found in the GS1 General Specifications GS1 Healthcare GTIN Allocation Rules and GS1 UDI support materials http www gs1l org healthcare udi Automatic Identification and Data Capture AIDC Marking Marking of the UDI on the medical device packaging and in some cases the medical device itself via an Automatic Identification and Data Capture AIDC Data Carrier technology is a primary requirement of the U S FDA UDI ruling The Data Carrier is the means used to transport the UDI with the medical device and retrieve its unique identification enabling access to the database stored information The GS1 System includes specifications for the use of both Barcode and RFID Data Carriers including but not limited to EAN UPC GS1 128 GS1 DataMatrix Barcode symbologies GS1 128 01 10857674002017 10 1152KMB 2345 678 3S1 DataMatrix 01 00614141987658 17 120831 10 A1B2C304ES 21 00098522 Selection of the appropriate GS1 Data Carrier is based upon a number of factors including the UDI to be encoded in the Data Carrier the distribution channel of the medical device available space for the Data Carrier among other criteria of
139. be subjected Code List Name Population Guidance below This GUDID attribute will have several different mappings from GDSN based on the needed piece of information To provide Temperature information to the GUDID the GDSN attribute teperatureQualifierCode is in a repeatable group of attributes which include minimumTemperature maximumTemperature and temperatureMeasurementUnitCode Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Temperature will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Temperature will be provided To provide Humidity information to the GUDID the GDSN attribute humidityQualifierCode is in a repeatable group of attributes which include minimumHumidityPercentage and maximumHumidityPercentage Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Humidity will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Humidity will be provided The GDSN attributes correlating to the GUDID attributes for atmospheric pressure are temporary attributes AVP in GDSN They will be deployed into the GDSN Schema in 2016 17 into a
140. be added but cannot be edited or deleted Size Unit of Measure FDA GUDID The unit of measure associated with each clinically relevant size SPL Text The unit of measure associated with each clinically relevant size The unit of measure must conform to UCUM standards Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required Required if device is available in more than one size Data Type amp Length N A Entry List of Values LOV For length Centimeter Decimeter Feet Femtometer Inch Kilometer Meter Micrometer Millimeter Nanometer Picometer Yard For area Square centimeter Square foot Square inch Square meter Square millimeter For weight Gram Kilogram Microgram Milligram Metric Ton Pound Ton For total volume Centiliter Cubic Inch Cup Deciliter Femtoliter Fluid Ounce Gallon Kiloliter Liter Microliter Milliliter Nanoliter Picoliter Pint Quart For gauge French Gauge For angle Degree For pressure Pound per Square Inch millibar KiloPascal Units per Liter Hertz Millibar SPL Text UCUM list of allowable values New DI Trigger NO Public Private Status Public GS1 GDSN Module AVP Content Attribute Role clinicalSizeValue actual AVP name ends in 1 2 3 or 4 to allow grouping of AVP attributes Datat
141. be completed by a healthcare provider prior to initial use of the healthcare trade item Sterilisation refers to any process that effectively kills or eliminates transmissible agent Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 216 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline MedicalDeviceTradeltemModule Code List Name SterilizationTypeCode 6 61 Population Guidance below The GDSN attribute initialSterilirilizationPrior oUseCode is a code list indicating the type s of sterilization which should be performed on a device by a Provider prior to use Population of a value for this attribute signifies that the device is not sold as sterile and that the Provider does need to sterilize it prior to use using the method populated If a code value is published in the GDSN then a value of TRUE will be populated in the GUDID for Requires Sterilization Prior to Use If no value is published in GDSN then a value of FALSE will be populated in the GUDID Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited Sterilization Method FDA GUDID Description Indicates the method s of sterilization that can be used for this device Data Entry
142. be disposable depending on the product hierarchy Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 111 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Package Type Package Type Case Carton packagingTypeCode packagingTypeCode cS CT Case Carton A non specific term for a container designed to hold house and sheath or encase its content while protecting it during distribution storage and or exhibition Cases are mostly intended to store and preserve its contents during the product s entire lifetime A non specific term for an open or re closable container used mostly for perishable foods e g eggs or fruit Package Type Cup Tub packagingTypeCode CU Cup Tub A flat bottomed container that has a base of any shape and which may or not be closed with a lid Usually made of paper plastic or other materials these containers are typically used to contain mostly but not exclusively foods such as ice cream margarine yogurt sour cream confections etc Package Type Package Type Package Type Cylinder Envelope Gable Top packagingTypeCode packagingTypeCode packagingTypeCode CY EN GTG
143. but since address is not displayed to the GUDID public user this is not a requirement for data consistency All edits to information connected to the Labeler DUNS Number must be done through Dun amp Bradstreet No edits of DUNS information will be permitted in the GUDI D Edit Rules After Grace Period Edit Editing of entered data is allowed Other Labeler DUNS listed to your GUDID account can be selected No Edit Editing of entered data is allowed s of DUNS info will be permitted Required Required Data Type amp Length NA Entry List of Values LOV Labeler DUNS LOV Webtool New DI Trigger NO Public Private Status Private GS1 GDSN requires 2 GDSN attribute to denote the GUDID Labeler DUNS Module PartylnRole Content Attribute Attribute Role additionalPartyldentification Datatype Secondary Class string Text 1 80 Characters Multiplicity Mandatory If module is invoked Occurrence Single Definition Identification of a party by use of a code other than the Global Location Number Code List Name Module AdditionalkKeyDataTypes Content Attribute Attribute Role additionalPartyl dentificationTypeCode Datatype Secondary Class Code Multiplicity Mandatory If module is invoked Occurrence Single Definition Identification of a party by use of a code in addition to the Global Location Number Code List Name AdditionalPartyldentificationTypeCode
144. bute AVP in GDSN clinicalSizeType It will be deployed into the GDSN Schema in 2016 17 into a final solution All of the clinical attributes can be repeated as a group when this value changes In the temporary solution the attribute names end in the numbers 1 2 3 and 4 All of the attributes ending in the same number are in a group together and relate to each other This numbering will be removed in the final GDSN solution This GUDID attribute is a Code List clarifying the qualifier type associated to the clinical size values For example as syringe is measured by the gauge of the needle and or the volume it can contain For the type this attribute might be populated with NEEDLE_GAUGE and or TOTAL_VOLUME This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 200 of 218 6 52 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline There is an option to specify a textual value for a clinical size type which has not been specified in the value and UoM attributes When this attribute is published with the value of DEVICE_SIZE_TEXT SPECIFY the GDSN attribute clinicalSizeText becomes required Once published a 7 day grace period begins During the grace period most attributes can be edited
145. c AVP transportationEnviro Handling entAtmosphericPressMi pressure in which the item transportationEnvir nmentAtmosphericP Type n should be transported to onmentAtmospheri ressureMaximum remain usable This value is cPressureMinimum transportationEnviro the value below which the nmentAtmosphericP trade item should not be ressureMinimum subjected High Value AVP transportationEnvironm String Unit of measure for the AVP transportationEnviro SPL Name entAtmosphericPressMa attribute transportationEnvir nmentAtmosphericP Storage and xUoM transportationEnvironmentAt onmentAtmospheri ressureMaximum Handling High mosphericPressMax cPressureMaximum Value Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 86 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Value Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Unit of AVP transportationEnvironm String Unit of measure for the AVP transportationEnviro Measure SPL entAtmosphericPressMa attribute transportationEnvir nmentAtmosphericP Name xUoM transportationEnvironmentAt onmentAtmospheri ressureMaximum Storage and mosphericPressMax cPressureMaximum Handling Unit of Measure Low Value AVP transportat
146. c PACK_OR_INNER_PACK 0061414111111c 4 4 boxes ina carton 0061414111111c BASE_UNIT_OR_EACH N A N A 1 Box of Gloves Hierarchy Number 2 globalTradeitemNu mber 4061414111111c 3061414111111c 0061414111111c tradel temUnitDescri ptor CASE PACK_OR_INNER_P ACK BASE_UNIT_OR_EA CH ChildTradeltem globalTradeltem Number 3061414111111 Cc 0061414111111 Cc N A quantityofNextL owerLevelTrade Item 10 N A 2 cartons in a case 10 boxes in a carton 1 Box of Gloves Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 171 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline This is converted to the following for population in the GUDI D Package DI Number Quantity per Contains DI Package Notes package 1061414111111c 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111c 5 3061414111111c Indicates there are 5 packs in the case 3061414111111c 10 0061414111111c Indicates there are 10 eaches in the pack 4061414111111c 2 3061414111111c Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be deleted 6 23 Package Type FDA GUDID Description Text to describe the outer packaging of the product and enables
147. ce below This Boolean attribute should be populated with a value of TRUE when there is any amount of human tissue as part of the device Otherwise the value should default to FALSE 6 29 Kit FDA GUDID Description Indicates that the device is a convenience combination in vitro diagnostic IVD or medical procedure kit Kits are a collection of products including medical devices that are packaged together to achieve a common intended use and is being distributed as a medical device Data Entry Notes Select checkbox if DI record is for a kit Do not check if the device is a constituent part of a kit Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Optional Data Type amp Length Type Boolean Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role groupedProduct Datatype Secondary Class Code Multiplicity Optional Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 178 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline AVP Module Occurrence Single Definition Code representing if the trade item is considered by the manufacturer to be more than a Code List Name GroupedProductCode KIT or KIT_AND_COM
148. ce below This GDSN attribute is a code list of values signifying how the item is presented for sale to a consumer If a value of OTC is published in the GDSN attribute consumerSalesConditionCode attribute a value of TRUE will be populate in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute What MRI safety information does the labeling contain FDA GUDID Description Indicates the MRI Safety Information if any that is present in the device labeling Please see the ASTM F2503 13 standard for more information Data Entry Notes Choose a value from the drop down LOV The final rule does not require MRI compatibility testing it only requires submission of information regarding MRI compatibility that the labeler already possesses Webtool Edit Rules After Grace Period Edit Editing of entered data is allowed ONLY if changing from Labeling does not contain to other MR status Safe Unsafe Conditional data element is not able to be changed directly most are auto populated fields whose information depends on another data element l Otherwise NO changes are allowed Required Required Data Type amp Length N A Entry List of Values LOV MR Safe MR Unsafe MR Conditional Labeling does not contain MRI Safety information New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute
149. ce label but since this data element is not be displayed to the GUDID public user this is not a requirement for data consistency auto populated fields whose information depends on another data element Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 30 of 218 Data Element Brand Name Description The Proprietary Trade Brand name of the medical device as used in device labeling or in the catalog This information may 1 be on a label attached to a durable device 2 be on a package of a disposable device or 3 appear in labeling materials of an implantable device The brand name is the name that is typically registered with USPTO and have the and or symbol Data Entry Notes Enter the Brand Name Only symbols and will be supported for the current production release of GUDID NOTE per Edit Rules you will not be able to change or if entered after the Grace Period Enter NA if the device does not have a Brand Name Edit Editing of entered data is allowed Rules after Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Alphanum Length 80 Entry List of Values LOV NA New DI Trigger YES Public Private Status Public Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guidelin
150. cord you must submit the original premarket authorization number and the supplement number through which you obtained approval for the version or model identified in that DI record as required by 830 310 b 11 Although not all PMA supplements are applicable to a given model or version if FDA approves a subsequent supplement applicable to that version or model the GUDID DI record must be updated with that supplement number in accordance with 21 CFR 830 330 b 30 day notice supplements should be submitted ONLY if the 30 day notice impacts the device design specifications or performance of the finished devices Do not enter alpha characters Example Supplement 4 should be entered as 004 Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required Premarket Submission Number OR exempt status fulfills regulatory requirement GS1 GDSN requires 2 GDSN attributes to denote the GUDID FDA Premarket Submission Number Data Type amp Length Type Num Length 4 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public Module GDSNTradeltemClassification Content Attribute Attribute Role AdditionalTradel temClassificationS ystemCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition The Classification System for the Additional Trade Item Classification Code List Name Additi
151. d the data element Size Type Text will appear see below It is expected that the Size Text specify will only be available for a limited time Use this option to help us build a list of values that are appropriate for your device type GUDID reserves the right to review all suggestions before adding values to the Size Type LOV More than one Size Value per Type and more than one Size Type may be added to each DI record Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required 1f device is available in more than one size Data Type amp Length N A Entry List of Values LOV Circumference Depth Device Size Text specify Catheter Gauge Outer Diameter Height Length Lumen Inner Diameter Needle Gauge Total Volume Width Weight Pressure Pore Size Area Surface Area Angle New DI Trigger NO Public Private Status Public GS1 GDSN Module AVP Content Attribute Role clinicalSizeType actual AVP name ends in 1 2 3 or 4 to allow grouping of AVP attributes Datatype Secondary Class Code Multiplicity Optional Occurrence Size Definition The qualifier to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example needle gauge for a 16 gauge needle or volume for a 200 cc syringe Code List Name Population Guidance below This attribute has a temporary attri
152. data is allowed Rules New DI Public Private Required Data Type amp Length Entry List of Values LOV Element Prescription Status after Grace Period Trigger Status Prescriptio Indicates that the device requires a Select checkbox if Add Addition of new Optional Type NA NO Public n Use Rx prescription to use appropriate data is allowed Boolean Can select both Rx Delete Deletion of If no data and OTC for one DI entered data is is record allowed provided Edit Editing of entered No is data is allowed stored Over the Indicates that the device does not Select checkbox if Add Addition of new Optional Type NA NO Public Counter require a prescription to use and can appropriate data is allowed Boolean OTC be purchased over the counter Can select both Rx Delete Deletion of If no data OTC and OTC for one DI entered data is is record allowed provided Edit Editing of entered No is data is allowed stored MRI Safety Status What MRI Indicates the MRI Safety Choose a value from Edit Editing of entered Required NA MR Safe NO Public safety Information if any that is present in the drop down LOV data is allowed MR Unsafe informatio the device labeling Please see the MR n does the ASTM F2503 13 standard for more The final rule does ONLY if changing from Conditional labeling information not require MRI Labeling does not Labeling does contain compatibility testin
153. degrees apart Environment UoM Atmospheric transportationMaximu Pressure mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a and Handling Celsius eratureMaximum temperature scale the freezing point of water is O Units of UoM degrees Celsius C and the boiling point 100 C Measure storageHandlingTemp at standard atmospheric pressure placing the Handling eratureMinimum boiling and freezing points of water exactly 100 Environment UoM degrees apart Atmospheric transportationMaximu Pressure mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to 1 273 16 of the absolute temperature of the triple point of water One kelvin degree is equal to one Celsius degree Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 134 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Handling Environment Humidity Fahrenheit eratureMaximum UoM storageHandlingTemp eratureMinimum
154. devices delete are allowed Num Example Length 7 Base Package Box of 100 gloves Primary DI 101 Device Count 100 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 27 of 218 Data Element Unit of Use DI Number Description An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use Its purpose is to associate the use of a device to on a patient Data Entry Notes Enter the Unit of Use DI Number Must be from same Issuing Agency as Primary DI Unit of Use DI is an identifier used by hospital staff and Materials Management to account for a single device when the UDI is labeled on a higher level of packaging The Unit of Use DI does not appear on the label Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters CCBBA Alphanumeric with 10 or 16 characters If Device Count 1 cannot add Unit of Use DI Number Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Edit Editing of entered data is allowed Required Conditional ly Required If Device Count gt 1 Data Type amp Length Type
155. e Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 31 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Version The version or model found on the Enter the Version or None NO edit add or Required Type NA YES Public or device label or accompanying Model delete are allowed Alphanum packaging used to identify a Model category or design of a device The Version Model can be Length 40 version or model identifies all any distinguishing devices that have specifications string of letters performance size and composition and or numbers within limits set by the labeler Catalog Number can be entered if device does not currently have a Version or Model If the device does not have a version model or catalog number enter a concept that can be used to identify all devices that have specifications performance size and composition within limits set by the labeler Catalog The catalog reference or product Enter the Catalog or Add Addition of new Optional Type NA NO Public Number number found on the device label or Reference Number data is allowed Alphanum accompanying packaging to identify Delete Del
156. e 2 0 Ratified Oct 2015 and can no longer be edited 2015 GS1 AISBL Page 147 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 2 Primary DI FDA GUDID Description An identifier that is the main primary lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use The primary DI number will be located on the base package which is the lowest package level of a medical device containing a full UDI For medical devices without packaging the primary DI number and full UDI may be on the device itself Data Entry Notes Enter the Device Identifier DI Number Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV NA New DI Trigger YES Public Private Status Public GS1 GDSN yowe oreren Content GTIN generalization Attribute Role GTIN Datatype Secondary Class Tradel teml dentification Multiplicity GDSN Mandatory Occurrence Single Definition Trade Item Identificati
157. e Units of height width depth 0 3048 meters Measure and netContent Outer Diameter Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 127 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimeters Measure and netContent Outer Diameter UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Outer Diameter UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Outer Diameter UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Outer Diameter UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure
158. e accomplished by the population of the code value MODEL_NUMBER in the GDSN attribute additionalTradelteml dentificationTypeCode The actual Model Number can then be populated in the GUDID using the associated additionalTradel teml dentification Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 155 of 218 6 10 Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline The code value of MODEL _ NUMBER is defined as The Additional Trade Item Identification value populated is an identification number which defines the configuration of the product in addition to the Item number This is typically printed or otherwise attached to an item In electronics this number is typically found around or near a serial number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited This group of attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Catalog Number Secondary DI Number DM DI Number and FDA Listing Number Catalog Number FDA GUDI D The catalog reference or product number found on the device label or accompanying packaging to identify a particular product Data Entry Notes
159. e and which may or not be closed with a lid Pots are usually made of cardboard plastic ceramic metal or other materials and may be used for a wide array of products such as cosmetics food liquids dairy products plants Package Type Tray packagingTypeCode PU Tray A shallow container which may or may not have a cover used for displaying carrying items or carry for warehousing Examples for TIIG e Plate e Cardboard carrier Cellplate Divider Sheet Slip Sheet Plastic Wrapped Tray Tray for bottles Tray one layer no cover Tray tablet Tray Shrinkpacked Tray Tray pack Other Information e This code also covers all ready to cook plates in which some products are sold Divider Sheets Slip Sheets which are used to hold layers on a pallet for efficient cross docking warehousing processes Package Type Packed unspecified packagingTypeCode PUG Packed unspecified Packaging of the product or products is currently not on the list Use this code when no suitable options are available and only while a Change Request is approved for the proper packaging type Package Type Pallet packagingTypeCode PX Pallet A platform used to hold or transport unit loads Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 114 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global
160. e data to the GUDID a GTIN can not bea Secondary DI However the item might have a Secondary DI from another issuing agency s item number standard Using the pair of GDSN attributes additionalTradelteml dentificatonTypeCode and additionalTradelteml dentificaton these other issuing agency identifiers can be provided Currently there are code values for other issuing agencies which would have an associated additionalTradeltemldentificaton provided to the GUDID If a value is populated for additionalTradeltemldentificaton through GDSN for an issuing agency using the attribute additionalTradel teml dentificatonTypeCode it will be provided to the GUDID as a secondary DI The codes available for the Secondary DI Issuing Agency are HIBC ICCBBA FDA_NDC_10 and FDA_NDC_11 The population of one of these additionalTradel teml dentificatonTypeCode values will denote the appropriate issuing agency code value for GUDID This value is paired with the GDSN attribute additionalTradelteml dentification Where this attribute is populated with a value of HIBC ICCBBA FDA_NDC_10 and FDA_NDC_11 then the associated value populated in additionalTradeltem dentification will be provided to the GUDID as the Secondary DI Number This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number C
161. e examples below In GDSN the following is provided Hierarchy Number 1 globalTradeitemNu mber tradel temUnitDescri ptor ChildTradeltem globalTradeltem Number quantityofNextL owerLevelTrade Item 2061414111111c CASE 1061414111111 5 5 cartons in a case c 1061414111111c PACK_OR_INNER_P 0061414111111 4 4 boxes in a carton ACK c 0061414111111c BASE_UNIT_OR_EA N A N A 1 Box of Gloves CH Hierarchy Number 2 globalTradeitemNu mber tradel temUnitDescri ptor ChildTradeltem globalTradeltem Number quantityofNextL owerLevelTrade Item e Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 169 of 218 globalTradeitemNu mber tradel temUnitDescri ptor ChildTradeltem globalTradeltem quantityofNextL owerLevelTrade Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Notes Number Item 3061414111111c PACK_OR_INNER_P 0061414111111 10 10 boxes in a carton ACK c 0061414111111c BASE_UNIT_OR_EA N A N A 1 Box of Gloves CH This is converted to the following for population in the GUDI D Package DI Number Quantity per Contains DI Package Notes package 1061414111111c 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111c 5 3061414111111c Indicates there are 5 packs in the case 3061414111111c 10 0061414111111c Indicates there are 10 eaches
162. e of the GDSN v2 8 Attribute from which the row was mapped This column will assist users as they migrate from GDSN v2 8 to GDSN v3 1 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 65 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Device Information Device Identifier DI Information Issuing _ LOGICAL Data Pool to default Agency POPULATION On on outbound the outbound FDA message GUDID Message by the Data Pool Will use the value GS1 in all GDSN instances Primary DI Coreltem GTIN GTIN Tradeltemldentific Trade Item Identification for globalTradel temNu Number generalization ation a Tradeltem mber Device Count AVP uDI DDeviceCount Integer The count of medical devices Only populated at uDI DDeviceCount which are contained inside the lowest level of the base item for regulatory the hierarchy purposes N A Coreltem Attribute componentNumber nonNegativelntege Indicate a sequence number r of a component of a trade item Unit of Use DI Coreltem Attribute componentl dentificatio Identifier GTIN An identifier for a fDAUnitOfUseGTIN Number n component Labeler DUNS Additional Attribute additionalPartyl dentific Code Identification of a party by Brand owner GLN additional
163. ed Occurrence Single Definition This code will be used to cross reference the Vendors internal trade item number to the GTIN in a one to one relationship Code List Name AdditionalTradeltemldentificationTypeCode DIRECT_PART_MARk Module GS1ldentificationComponents Content Attribute Attribute Role additionalTradelteml dentification Datatype Secondary Class AdditionalTradeltemldentification Multiplicity Mandatory If module is invoked Occurrence Single Definition Alternative means to the Global Trade Item Number to identify a trade item Code List Name N A Population Guidance below This should only be populated if there is a Direct Part Mark on the Device AND the DI used in the Direct Part Mark is NOT the same as the Primary DI This attribute has a temporary attribute AVP in GDSN directPartMarking It will be deployed into the GDSN Schema in 2016 17 into a final solution Population of the GDSN Attribute additionalTradel teml dentificatonTypeCode with a value of DIRECT_PART_MARK will allow for the appropriate value to be populated in additionalTradelteml dentificaton This attribute pair can be repeated for as many DPM DI s the item might have The value populated in the GDSN attribute additionalTradel teml dentificaton attribute and associated with the additionalTradel teml dentificatonTypeCode of DIRECT_PART_MARK is what will be populated in the GUDID This group of
164. ed to facilitate correcting the data Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can only be changed with Dunn and Bradstreet D amp B Many of the data elements are locked and can no longer be edited Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 153 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 8 Brand Name FDA GUDID Description The Proprietary Trade Brand name of the medical device as used in device labeling or in the catalog This information may 1 be on a label attached to a durable device 2 be on a package of a disposable device or 3 appear in labeling materials of an implantable device The brand name is the name that is typically registered with USPTO and have the and or TM symbol Data Entry Notes Enter the Brand Name Only symbols and will be supported for the current production release of GUDID NOTE per Edit Rules you will not be able to change or if entered after the Grace Period Enter NA if the device does not have a Brand Name Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Alphanum Length 80 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1
165. ed to the GUDID For pressures the unit of measure value populated as part of the GDSN temporary attributes transportationEnvironmentAtmosphericPressMin transportationEnvironmentAtmosphericPressMax storageEnvironmentAtmosphericPressuerMinimum and storageEnvironmentAtmosphericPressureMaximum will be mapped to the GUDID For humidity the data pool will auto populate the GUDID with a value of percentage or percent Special Storage Conditions FDA GUDID Description Indicates any special storage requirements for the product SPL Text Indicates Data Entry Notes Enter any other storage conditions any special storage requirements for the product For devices kept at room temperature or other standard conditions input that information here Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 214 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description Indicates any special storage requirements for the product SPL Text Indicates any special storage requirements for the product Required Conditionally Required Required if Special Storage Conditions is selected above Data Type amp Length Type Alphanum Length 200 Entry List of Values LOV
166. eference on the Trade the Global Data containing odule Item s labeling Dictionary but will natural be changed in a rubber latex future GDSN or dry natural release to the rubber 21 definition and CFR wording at this 801 437 link Please use this new wording when populating the attribute Device HealthWel Attribute packagingMarkedFreeFr Code Indication of the food Use value of packageMarksFreeFr labeled as InessPack omCode ingredients that the package FREE_FROM_LATEX om Not made agingMark is marked free from with natural ingModule rubber latex Prescription Status Prescription SalesInfor Attribute consumerSalesConditio Code A code depicting restrictions Use value of ConsumerSalesCond Use Rx mationMo nCode imposed on the Trade Item PRESCRIPTION_RE_ ition dule regarding how it can be sold QUIRED to the consumer for example Prescription Required Over the SalesInfor Attribute consumerSalesConditio Code A code depicting restrictions Use value of OTC ConsumerSalesCond Counter mationMo nCode imposed on the Trade Item ition OTC dule regarding how it can be sold to the consumer for example Prescription Required MRI Safety Status What MRI MedicalDe Attribute mRI CompatibilityCode Code This is an identification of the mRI Compatibility safety viceTradel compatibility of a trade item information temModul for use in the presence of a does the e Magnetic Resonance I maging labeling MRI system contain
167. efinition Secondary DI HI BCC additionalTradel teml d Health Industry Business Communication Barcode Number entification An alphanumeric identification number used as a common identifier within the healthcare industry across different locations In the Netherlands this code is managed by the European Health Industry Business Communications Council Secondary DI ICCBBA CODE PENDI NG Number Version or additionalTradeltemld MODEL_NUMBER Model Number An identification number which defines the Model entification configuration of the product in addition to the Item Release 2 0 Ratified Oct 2015 2015 GS1 AISBL number This is typically printed or otherwise attached to an item In electronics this number is typically found around or near a serial number Page 94 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute Description where Code Group applicable Catalog Number additionalTradeltemid SUPPLIER_ASSIGNED Supplier Assigned The additional Trade Item Identification value entificationTypeCode populated has been developed and assigned by the party which provides service s and or manufactures or otherwise has possession of the goods and consigns or makes them available in trade This number is a base model or style number assigned to
168. efinition GDSN Notes GDSN v2 8 Attribute Name Product Code GDSNTrad Attribute additionalTradeltemCla Code The Classification System for Use code 43 additionalClassificati eltemClas ssificationSystemCode the Additional Trade Item onAgencyName sification Classification Product Code Tradeltem Attribute additionalTradeltemCla AdditionalTradelte Category code based on Code value additionalClassificati Classificati ssificationCode mClassificationCod alternate classification managed by FDA onCategoryCode on e schema chosen in addition to the Global Product Classification GPC Product Code FDA will populate Name based on the FDA Product Code FDA Listing FDA Listing AVP fDAMedicalDeviceListin String Most Owners or operators of AVP fDAMedicalDeviceLis Number g places of business also fDAMedicalDeviceLi ting AVP called establishments or sting facilities that are involved in the production and distribution of medical devices intended for use in the United States U S are required to list the devices that are made a Future Additional Attribute additionalTradeltemide Code This code will be used to Code to be additionalTradel tem change KeyDataT ntificationTypeCode cross reference the Vendors determined when I dentificationType ypes internal trade item number deployed in 2016 to the GTIN in a one to one relationship Future GSlldenti Attribute additionalTr
169. ement The maximum pressure at AVP storageEnvironment Measure SPL mosphericPressureMaxi which the trade item can be storageEnvironmen AtmosphericPressur Name mum stored and handled This tAtmosphericPress eMaximum Storage and uses a measurement ureMaximum Handling Unit consisting of a unit of of Measure measure and a value Low Value AVP storageEnvironmentAt Measurement The minimum pressure at AVP storageEnvironment SPL Name mosphericPressureMini which the trade item can be storageEnvironmen AtmosphericPressur Storage and mum stored and handled This tAtmosphericPress eMinimum Handling Low uses a measurement ureMinimum Value consisting of a unit of measure and a value Unit of AVP storageEnvironmentAt Measurement The minimum pressure at AVP storageEnvironment Measure SPL mosphericPressureMini which the trade item can be storageEnvironmen AtmosphericPressur Name mum stored and handled This tAtmosphericPress eMinimum Storage and uses a measurement ureMinimum Handling Unit consisting of a unit of of Measure measure and a value Storage and Tradeltem Attribute humidityQualifierCode Code Code qualifying the type of a storageHandlingHu Handling Humidity temperature for example midityMaximum Type nformatio STORAGE storageHandlingHu nModule midityMinimum High Value Tradeltem Attribute maximumHumidityPerc Decimal The maximum humidity in storageHandlingHu SPL Name Humidity entage percentages that the goods midityMaximum Storage
170. emperature UoM and transportationMinimu mTemperature UoM UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a temperature scale the freezing point of water is 0 degrees Celsius C and the boiling point 100 C at standard atmospheric pressure placing the boiling and freezing points of water exactly 100 degrees apart Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 137 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to and Handling eratureMaximum 1 273 16 of the absolute temperature of the triple Units of UoM point of water One kelvin degree is equal to one Measure storageHandlingTemp Celsius degree Handling eratureMinimum Environment UoM Temperature transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling tmosphericPressureM Units of aximum UoM Measure storageEnvironmentA Handling tmosphericPressureMi Environment nimum UoM Tempe
171. equires bulky shielding for the safety of the operators they also require storage of a radioisotope usually Cobalt 60 which continuously emits gamma rays it cannot be turned off and therefore always presents a hazard in the area of the facility Device TRUE initialManufacturerSter SOUND_WAVES This is a code value for population with the AVP Packaged as ilisationCode attribute extended nitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialManufacturerSter SUPERCRITICAL_CARBON_ This is a code value for population with the AVP Packaged as ilisationCode DIOXIDE attribute extended nitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialiManufacturerSter UV_LIGHT Useful for sterilisation of surfaces and some Packaged as ilisationCode transparent objects Many objects that are Sterile transparent to visible light absorb UV UV irradiation is routinely used to sterilize the interiors of biological safety cabinets between uses Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 102 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where
172. ers Measure and netContent Length UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure and netContent Length Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 124 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure and netContent Length UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is equal to one tenth of a metre Size Units of height width depth Measure and netContent Length UoM Length fm Femtometer clinicalSizeValue Dimension A71 Femtometre Femtometre a quadrillionth of a metre 10 to the Size Units of height width depth negative 15th power Measure and netContent Length UoM Length km Kilometer clinicalSizeValue Dimension KMT Kilometre A kilometre is one thousand 1000 metres Size Units of height width depth Measure and netContent Length UoM Length m Meter clinicalSizeValue Dimension MTR Metre The metre is the basic
173. es The Data Governance policies should include clear determination documentation and enterprise wide education of the Roles and Responsibilities of each function across the information supply chain This should include a determination of how data is managed within an organisation and the roles associated with the process Generally speaking there are two overarching models centralized or decentralized Most commonly the responsibilities are spread across an entire organisation ranging from manufacturing to product management to regulatory affairs Which model applies to a particular organisation depends on many factors such as organisational structure size and policies related to corporate versus division autonomy and perhaps even legal incorporation of the various divisions which make up the organisation There are many models for establishing and documenting Roles and Responsibilities The first step should be to determine if your organisation has a corporate philosophy or policy for assigning roles and responsibilities for information lifecycle management If not a basic place to start might be the RACI model R Responsible owns the project problem or task The person responsible for doing the work to achieve the task A to whom the R is Accountable who must sign off approve work before it is effective C to be Consulted has information and or capability necessary to complete the work I to be Informed must be not
174. es LOV New DI Trigger R Public Private Status Lot or Indicates the device is managed by Choose Yes No from Add Addition of new Required Type Yes No NO Public Batch lot or batch number This number the drop down list data is allowed Boolean Number can be found on the device label or Delete Deletion of packaging Lot or Batch means one For stand alone entered data is finished device or more that consist software select Yes allowed of a single type model class size to indicate that the Edit Editing of entered composition or software version that software version data is allowed are manufactured under essentially number will be the same conditions and that are represented as a Lot intended to have uniform or Batch number characteristics and quality within specified limits Manufactu Indicates the device is managed by Choose Yes No from Add Addition of new Required Type Yes No NO Public ring Date date of manufacture the date a the drop down list data is allowed Boolean specific device was manufactured Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Serial Indicates the device is managed by Choose Yes No from Add Addition of new Required Type Yes No NO Public Number serial number This number can be the drop down list data is allowed Boolean found on the device label or Delete Deletion of packaging The serial number is entered data is assigned by the labeler and s
175. essure at which the trade item can be stored and handled This uses a measurement consisting of a unit of measure and a value Code List Name Module Content Attribute Role transportationEnvironmentAtmosphericPressMin Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected Code List Name Population Guidance below This GUDID attribute will have several different mappings from GDSN based on the needed piece of information Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 208 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline To provide Temperature information to the GUDID the GDSN attribute teperatureQualifierCode is in a repeatable group of attributes which include minimumTemperature maximumTemperature and temperatureMeasurementUnitCode Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Temperature will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Temperature will be provided To provide Humidity infor
176. et Submission Number Release 2 0 Ratified Oct 2015 AVP GDSNTrad eltemClas sification Attribute exemptFromFDAPreMar ketAuthorization additionalTradel temCla ssificationS ystemCode Boolean Code Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices Class III devices are those that support or sustain human life are of substantial importance in preventing impairment of human health or which present a potential unreasonable risk of illness or injury Due to the level of risk associated with Class III devices FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices Therefore these devices require a premarket approval PMA application under section 515 of the FD amp C Act in order to obtain marketing clearance Please note that some Class III preamendment devices may require a Class III 510 k See Historical Background2 for additional information The Classification System for the Additional Trade Item Classification 2015 GS1 AISBL AVP exemptFromFDAPr eMarketAuthorizati on External Code managed by FDA Use code 58 exemptFromFDAPre MarketAuthorization additionalClassificati onAgencyName Page 75 of 218 Leveraging GDSN for
177. etion of a particular product Catalog Reference entered data is Length 40 number can also serve as Version Model if it represents the devices that have specifications performance size and composition within limits set by the labeler allowed Edit Editing of entered data is allowed Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 32 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Device Additional relevant information about Enter device Add Addition of new Optional Type NA NO Public Descript the device that is not already description data is allowed Alphanum captured as a distinct GUDID data Delete Deletion of ion attribute Device description entered data is Length should include any allowed 2000 description found on Edit Editing of entered the device label to data is allowed support user comparison of the device label to the GUDID device record Otherwise include any additional description or text found in the device labeling Commercial Distribution DI Indicates the date the DI Record is Choose date from None NO edit add or Required Type NA NO P
178. evice states that the device must or should be used Data Entry Notes Choose Yes No from the drop down list Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role tradeltemDateOnPackagingTypeCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Indicates the type of date marked on the packaging for example Best Before Date Code List Name TradeltemDateOnPackagingT ypeCode Population Guidance below Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline This GUDID attribute is a Boolean clarifying how the item is controlled It will be mapped from the code values EXPIRATION_DATE or BEST_BEFORE_DATE in the GDSN attribute tradeltemDateOnPackagingTypeCode This attribute is not for the population of actual expiration dates Neither the GUDID nor GDSN are used to provide actual expiration dates These should be communicated in transactional documents such as packaging shipping and invoice documents A value populated of EXPIRATION_DATE or BEST_BEFORE_DATE for the GDSN attribute tradel temDateOnPac
179. f the clinical attributes can be repeated as a group when this value changes In the temporary solution the attribute names end in the numbers 1 2 3 and 4 All of the attributes ending in the same number are in a group together and relate to each other This numbering will be removed in the final GDSN solution This GUDID attribute is a measurement attribute specifying the clinical measure of the device This attribute is a numeric value and an associated Unit of Measure UoM qualifier The UoM is a code Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 201 of 218 6 53 Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline from the UN Recommendation 20 Code List The Data Pools will convert the UN Rec 20 code to the applicable code for the GUDID if needed For the GUDID the data pools will populate the numeric value in the GUDID attribute Size Value and the UoM qualifier in the GUDID attribute Size Unit of Measure For example for a 16 gauge needle the value is 16 and the UoM is H79 for a 20 cc syringe the value is 20 and the UoM is CQM This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can
180. final solution The GDSN attributes are in two pairs One pair is for the GUDID storage pressure attributes storageEnvironmentAtmosphericPressureMinimum and storageEnvironmentAtmosphericPressureMaximum The other pair is for the GUDID transportation pressure transportationEnvironmentAtmosphericPressMin and transportationEnvironmentAtmosphericPressMax The applicable storage type can be derived from the attribute name The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes for pressure Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 211 of 218 GUDID Storage Type Code GDSN Attributes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Storage environment atmospheric pressure storageEnvironmentAtmosphericPressureMaximum AVP storageEnvironmentAtmosphericPressureMinimum Handling environment atmospheric pressure transportationEnvironmentAtmosphericPressMaximum AVP transportationEnvironmentAtmosphericPressMinimum For the GUDI D the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and others have a single
181. g Package Type Net packagingTypeCode NT Net A container of meshwork material made from threads or strips twisted or woven to form a regular pattern with spaces between the threads that is used for holding carrying trapping or confining something Package Type Pallet Box packagingTypeCode PB Pallet Box A three dimensional container which either has a pallet platform permanently attached at its base or alternatively requires a platform for its handling and storage as due to its constitution it cannot be handled without it The characteristics of the platform should be specified using the pallet type code list Package Type Peel Pack packagingTypeCode PLP Peel Pack A package used for sterile products which may be torn open without touching the product inside Package Type Pouch packagingTypeCode PO Pouch A preformed flexible container generally enclosed with a gusset seal at the bottom of the pack can be shaped arranged to allow the pack to stand on shelf Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 113 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Package Type Pot packagingTypeCode PT Pot A flat bottomed container that has a base of any shap
182. g contain to other MR not contain it only requires status Safe Unsafe MRI Safety submission of Conditional data information Release 2 0 Ratified Oct 2015 information regarding MRI compatibility that the labeler already possesses element is not able to be changed directly most are auto populated fields whose information depends on another data element I Otherwise NO changes are allowed 2015 GS1 AISBL Page 55 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Size Type Dimension type for the clinically Choose a value from Add Addition of new Conditional NA Circumferen NO Public relevant measurement of the the drop down LOV data is allowed ly ce Depth medical device Required Device Size If the desired Size Text Type is not in the If device specify current list select is available Catheter Size Text specify in more Gauge and the data element than one Outer Size Type Text will size Diameter appear see below Height It is expected that Length the Size Text Lumen Inne specify will only be r Diameter available for a limited Needle time Use this option Gauge Total to help us build a list Volume of values that are Width appropriate for your Weight device type GUDID Pressure reserves the right to Pore Size review all Area Surfac s
183. g for a descriptive term Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 172 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline and not the code There is a mapping list from which the data pools can populate the appropriate descriptive term to publish to the GUDID in section 6 of this document Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be deleted 6 24 Package Discontinue Date FDA GUDID Description Indicates the date this particular package configuration is discontinued by the Labeler Data Entry Notes Choose date from calendar or manually enter in format yyyy mm dd Discontinuation of a package is directly related to the discontinuation of the primary DI of the base package However a package can also be discontinued without the discontinuation of the base package Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required If Package DI Number and Commercial Distribution End Date are entered must also enter Package Discontinue Date Data Type amp Length Type Num date format Length 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role discontinuedDateTime Datatype Seconda
184. ge system as it is also known the diameter in millimeters of the catheter can be determined by dividing the French size by 3 thus an increasing French size corresponds with a larger diameter catheter The following equations summarize the relationships D mm Fr 3 or Fr D mm 3 UoM Gauge G Gauge clinicalSizeValue Dimension AWG Gauge A number referring to the outer diameter of Needle Units of height width depth hypodermic or suture needles Smaller gauge Measure and netContent numbers indicate larger outer diameters Inner Needle Gauge diameter depends on both gauge and wall thickness An increasing needle gauge size corresponds to a smaller diameter needle This is contrary to French Gauge where an increasing gauge size corresponds to a larger external diameter UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height width depth 0 3048 meters Measure and netContent Circumference Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 119 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Name Code Definition Code Attribute Code Group Code Group UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4
185. gh Values Field Minimum or Low Values Field Highest Value Leave Null provide no value Maximum or High Values Field Highest Value Greater Than a Value Minimum or Low Values Field Lowest Value Maximum or High Values Field Leave Null provide no value Single or Recommended Value Minimum or Low Values Field Single Same Value populated in both fields Maximum or High Values Field i 6 56 FDA GUDI D Description Low Value SPL Name Storage and Handling Low Value Indicates the low value for storage and handling requirements SPL Definition Indicates the low value for storage requirements such as temperature humidity etc Data Entry Notes Edit Rules After Grace Period Enter a number for Low Value Must enter at least one value Low or High but can enter both Low Value and High Value if needed When Storage and Handling value is a range this is the lower end of that range When Storage and Handling value is less than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling High Value Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required One value Low or High is required if Storage and Handling Type is added to the device record Data Type amp Length Type Num Leng
186. ght Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 145 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Weight g Gram grossWeight and Mass GRM Gram A gram is defined as one one thousandth of the Units of netContent kilogram 1x10 3 kg Measure Weight UoM Weight kg Kilogram grossWeight and Mass KGM Kilogram A unit of mass equal to one thousand grams Units of netContent Measure Weight UoM Weight mg Milligram grossWeight and Mass MGM Milligram A milligram is one thousandth of a gram 0 001 Units of netContent Measure Weight UoM Weight t Metric Ton grossWeight and Mass TNE Tonne Metric ton 1000 Kg Units of netContent Measure Weight UoM Weight ug Microgram grossWeight and Mass MC Microgram A microgram is one millionth of a gram 0 000001 Units of netContent Measure Weight Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 146 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 Guidance on Populating Values This section provides guidance on how to populate each of the GS1 GDSN attributes to meet the requirements of the FDA GUDID at
187. gle patient Data Entry Notes during a single procedure Choose Yes No from the drop down list Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Boolean GS1 GDSN Module MedicalDeviceTradeltemModule Content Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public Attribute Attribute Role manufacturerDeclaredReusabilityT ypeCode Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 190 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module MedicalDeviceTradeltemModule Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Determines if the product is intended for single or multiple uses including the number of validated cycles and the number of times a product can be used according to the manufacturer specifications It is suggested that medical providers consult the device manufacturer s Instruction For Use IFU for full reusability instructions Code List Name HealthcareTradeltemReusabilityTypeCode Population Guidance below This GDSN attribute is a code list stating if the item can be used again When a value of S INGLE_USE or REUSABLE_SAME_PATIENT are populated for the GDSN attribute manufacturer
188. grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but cannot be edited or deleted Storage and Handling Type FDA GUDID Description Indicates storage and handling requirements that are required for the device Data Entry Notes Choose a value from the drop down LOV including temperature humidity and atmospheric pressure SPL Definition Indicates storage requirements are required for the device including temperature humidity etc Conditions of the Storage and Handling Type are measured below as a range with a Low Value and a High Value More than one Storage and Handling Type can be added per device record Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional Data Type amp Length N A Entry List of Values LOV Handling Environment Atmospheric Pressure Handling Environment Humidity Handling Environment Temperature Special Storage Conditions Storage Environment Atmospheric Pressure Storage Environment Humidity Storage Environment Temperature New DI Trigger NO Public Private Status Public Module GS1 GDSN for the GUDID temperature values TradeltemTemperaturelnformationModule Content Attribute Release 2 0 Ratified Oct 2015 2015 GS1 AISBL
189. groupedProduct trade item is considered by groupedProduct the manufacturer to be more KIT than a single item such as a kit combination item Combination AVP groupedProduct Code Code representing if the AVP groupedProduct Product trade item is considered by groupedProduct the manufacturer to be more than a single item such as a kit combination item COMBI NATION Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 73 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Module Content Attribute Role Datatype Definition GDSN Notes GDSN v2 8 Attribute Data Element Secondary Class Name Kit and AVP groupedProduct Code Code representing if the AVP groupedProduct Combination trade item is considered by groupedProduct Product the manufacturer to be more KIT_AND_COMBIN than a single item suchasa ATION Will kit combination item provide a TRUE value for both KIT and COMBINATION flags Premarket Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 74 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Device Exempt from Premarket Submission FDA Premark
190. gth um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure and netContent Outer Diameter UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height width depth 0 3048 meters Measure Pore and netContent Size UoM Length in_i Inch clinicalSizeValue Dimension INH Inches An international inch is defined to be equal to 25 4 Size Units of height width depth millimeters Measure Pore and netContent Size UoM Length yd_i Yard clinicalSizeValue Dimension YRD Yard A yard is It is equal to 3 feet or 36 inches or Size Units of height width depth 0 9144 meter Measure Pore Size and netContent Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 129 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length cm Centimeter clinicalSizeValue Dimension CMT Centimetre A centimetre is equal to one hundredth of a metre Size Units of height width depth Measure Pore and netContent Size UoM Length dm Decimeter clinicalSizeValue Dimension DMT Decimetre A decimetre is
191. hat is assigned to each donation Latex Information Device Indicates that the device or Choose Yes No from None NO edit add or Required Type Yes No YES Public required packaging contains natural rubber the drop down list delete are allowed Boolean to be that contacts humans as described labeled as under 21 CFR 801 437 Choosing containing Yes indicates that the device label natural or packaging contains one of the rubber following statements 1 Caution latex or This Product Contains Natural Rubber dry Latex Which May Cause Allergic natural Reactions 2 This Product Contains rubber Dry Natural Rubber 3 Caution 21 CFR The Packaging of This Product 801 437 Contains Natural Rubber Latex Which May Cause Allergic Reactions or 4 The Packaging of This Product Contains Dry Natural Rubber Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 53 of 218 Data Element Device labeled as Not made with natural rubber latex Description Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information Only applicable to devices not subject to the requirements under 21 CFR 801 437 Not all medical products that are NOT made with natural rubber latex will be marked Data Entry Notes Select checkbox if appropriate Only applicable if the response to
192. he data type of the GDSN attribute fDAMedicalDeviceListing AVP to alphanumeric 7characters Updated process for Premarket Submissions numbers and their related Supplement numbers Supplement numbers must be associated with an applicable Premarket Submission Number Updated the name of the FDA Premarket Submission Number in the FDA GUDID Column on the additional trade item classification agency tab Enter comment about name and definition changes being requested in GDSN Change the attribute used for the FDA GUDI D Publish date from effectiveDate to be fDAGUDI DPublishDate AVP and a final trading partner dependent deployment of uDI DPublishDate Updated the GDSN Notes for the GMDN Preferred Term and Definition attributes Corrected the MRI Compatibility codes to be all capitals Updated the guidance on the use of the Sterility codes Added code value of KIT_AND_COMBINATION to denote a TRUE value for both TRUE and COMBINATION Corrected GDSN Definitions for the additionalClassificaitonAgency which incorrectly only referenced Premarket Authorization Numbers Corrected truncated definitions in the packaging type code list Corrected the MRI Compatibility code for the GDSN from MRI_CONDITIONAL to the correct value from the GDSN Schema of MRI_COMPATI BLE Corrected missing words in the FDA Required column foe Supplement Number to complete phrase to state Not Required for Kits Updated guidance on how to populate the FDA Premarket Submissio
193. hould allowed be specific to each device Edit Editing of entered data is allowed Expiration Indicates the device is managed by Choose Yes No from Add Addition of new Required Type Yes No NO Public Date expiration date the date by which the drop down list data is allowed Boolean the label of a device states that the device must or should be used Release 2 0 Ratified Oct 2015 Delete Deletion of entered data is allowed Edit Editing of entered data is allowed 2015 GS1 AISBL Page 52 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Donatio Indicates the device is managed by a Choose Yes No from Add Addition of new Required Type Yes No NO n Donation Identification Number the drop down list data is allowed Boolean pe This number can be found on the Delete Deletion of Identific device label or packaging The This PI is only entered data is ation Donation Identification Number is applicable to HCT P allowed Number applicable to devices that are also products regulated as Edit Editing of entered regulated as HCT Ps and is a number medical devices data is allowed t
194. how to populate the FDA Premarket Submission Number and its associate Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 4 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Supplement Numbers Corrected the name of the Additional Classification header on the Additional Classification Agency code list tab to be Additional Classification Agency Name Corrections to the sheet Corrected the case for the clinical size text code list to be upper case Corrected the data type of the GDSN attribute fDAMedicalDeviceListing AVP to alphanumeric 7characters Updated process for Premarket Submissions numbers and their related Supplement numbers Supplement numbers must be associated with an applicable Premarket Submission Number Updated sheet based on updated guidance from the SPL Guide version 1 2 published by the FDA on 4 16 2014 Added a column for the SPL XPaths Added validation guidance for MR Safety Status Updated UoM sheet to group codes for clinical size types highlighted GDSN codes to be removed in the GDSN Major Release and highlights FDA GUDID Codes including GDSN Change Request to add Added tab containing guidance from the FDA on Premarket Submission Number formats Added new attributes for the Donation Identification Number FDA Preferred Term Code including GDSN Change Request to add Noted that the GUDID
195. humidity and atmospheric pressure SPL Definition Indicates the high value for storage requirements such as Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Data Entry Notes temperature humidity etc Enter a number for High Value Must enter at least one value Low or High but can enter both Low Value and High Value if needed When Storage and Handling value is a range this is the higher end of that range When Storage and Handling value is greater than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling Low Value Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required One value Low or High is required if Storage and Handling Type is added to the device record Data Type amp Length Type Num Length 6 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN for the GUDID temperature values Module TradeltemTemperaturelnformationModule Content Attribute Role Attribute maximumTemperature Datatype Secondary Class TemperatureMeasurement Multiplicity Optional Occurrence Single Definition The maximum temperature that a trade item can not exceed as defined by
196. ials used are chosen depending on the application Serial Number TRUE serialNumberLocationC MARKED_ON_TRADE_ITEM Serial number is on the trade item ode Serial Number FALSE serialNumberLocationC NOT_MARKED The trade item or its packaging is not marked ode Serial Number TRUE serialNumberLocationC MARKED_ON_PACKAGI NG Serial number is on the trade item s packaging ode Serial Number TRUE serialNumberLocationC MARKED_ON_PACKAGI NG Serial number is on the trade item s packaging ode _INSERT insert Serial Number TRUE serialNumberLocationC UNKNOWN Unknown location of marking ode Storage and Handling Type Storage Environment Temperature temperatureQualifierC ode STORAGE_HANDLING Trade Item is being stored or handled Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 116 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Storage and Handling Type Handling Environment Temperature temperatureQualifierC ode TRANSPORTATION Trade item is in process of being transported in the supply chain Manufacturing Date TRUE Manufacturing Date tradel temDateOnPack agingTypeCode PRODUCTION_DATE The production date is the
197. ide and Supercritical_ Carbon_ Dioxide 7 References For more information on UDI at a global level refer to http www gsl org healthcare udi For more information on the IMDRF refer to http www imdrf org For more information on the U S FDA UDI refer to http www gs1us org industries healthcare gs1 healthcare us fda udi For more information on the GDSN refer to http www gs1 org gdsn For more information on GS1 Healthcare refer to http www gsl org healthcare For country support contact your local GS1 Member Organisation http www gsl org contact For an interactive spreadsheet of the mapping from GDSN to FDA GUDID refer to http www gs1us org gs1 us library Command Core_Download amp Entryld 747 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 218 of 218
198. idth depth International System of Units SI Measure and netContent Depth UoM Length mm Millimeter clinicalSizeValue Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Size Units of height width depth Measure and netContent Depth UoM Length nm Nanometer clinicalSizeValue Dimension C45 Nanometre Nanometre a billionth of a metre 10 to the Size Units of height width depth negative 9th power Measure and netContent Depth UoM Length pm Picometer clinicalSizeValue Dimension C52 Picometre Picometre a trillionth of a metre 10 to the Size Units of height width depth negative 12th power Measure and netContent Depth Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 122 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Length um Micrometer clinicalSizeValue Dimension 4H Micrometre A micrometre is one millionth of a metre also Size Units of height width depth termed Micron Measure and netContent Depth UoM Length ft_i Feet clinicalSizeValue Dimension FOT Foot The international foot is defined to be equal to Size Units of height width depth 0 3048 meters Measure and netContent
199. ificationType ypes internal trade item number to the GTIN in a one to one relationship Version or GS1ldenti Attribute additionalTradeltemlde AdditionalTradelte Alternative means to the additionalTradeltem Model ficationCo ntification ml dentification Global Trade Item Number to I dentificationValue mponents identify a trade item Catalog Additional Attribute additionalTradeltemlde Code This code will be used to Use code value of additionalTradel tem Number KeyDataT ntificationTypeCode cross reference the Vendors SUPPLIER_ASSIGN IdentificationType ypes internal trade item number ED to the GTIN in a one to one relationship Catalog GS1ldenti Attribute additionalTradeltemlde AdditionalTradelte Alternative means to the additionalTradeltem Number ficationCo ntification ml dentification Global Trade Item Number to I dentificationValue mponents identify a trade item Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 67 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Device Tradeltem Description Descriptio nModule Attribute additionalTradel temDes cription Description500 Free Text 1 500 Characters Language Qualified Additional variants necessary to communicate to
200. ified of results need not be consulted This simple yet effective model can be applied in any size company In large organisations which include divisions in various parts of the world the roles and responsibilities are usually managed in decentralized manner Conversely in a small organisation everyone involved in the information management supply chain may be located in a single location The level of specificity depends on the granularity needed in order for the Master Data Management and Governance process to be effective and for it to meet its intended purpose For the purpose of UDI regulation the internal Regulatory Affairs function should be consulted as well GDSN Data Flow This section explains how to use the GDSN standard and GDSN certified Data Pools to register product data in the U S FDA Global UDI Database GUDID This section will be updated as other regulators introduce UDI regulation It should be noted that the U S FDA does not subscribe to a specific GDSN Data Pool and hence it is not a GDSN Data Recipient in the traditional meaning of this term This means that GDSN Data Sources cannot expect to publish their item master data to the U S FDA using their GDSN home data pool unless an additional service for this is offered by their GDSN Data Pool service provider However many labelers are GDSN Data Sources and wish to leverage their GDSN Data Pool to register data in the FDA GUDID in addition synchronising data with data rec
201. ifier Database GUDID Implementation Guideline 6 14 Commercial Distribution Status FDA GUDID Description Indicates whether the device is in commercial distribution as defined under 21 CFR 807 3 b Data Entry Notes Auto populated based on Commercial Distribution End Date If no Commercial Distribution End Date is entered the status is In Commercial Distribution Edit Rules After Grace Period N A data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length N A Entry List of Values LOV In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role Derived by the FDA GUDID based on uDIDPublishDate and lastShipDate Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below If the current date is equal to or greater than the GUDI D Publication Date uDIDPublishDate in GDSN then the GUDID attribute Commercial Distribution Status will be set to In Commercial Distribution automatically by the FDA If the current date is equal to or greater than the GUDID Commercial Distribution End Date lastShipDate in GDSN then the GUDID attribute Commercial Distribution Status will be set to Not in Commerci
202. in Handling Low nModule Page 87 of 218 FDA GUDID Module Content Data Element Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Unit of LOGI CAL Data Pool to default Measure SPL POPULATION on outbound Name Logical of message Storage and PERCENT from the Handling Unit population of any of Measure value in transportationHumi dityMaximum and or transportationHumi dityMinimum Special Consumer Attribute consumerStoragelnstru Description1000 Expresses in text the consumerUsageStor Storage Instructio ctions Free Text 1 1000 consumer storage agel nstructions Conditions nsModule Characters instructions of a product Language which are normally held on Qualified the label or accompanying Sterilization Method the product This information may or may not be labeled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement Allows for the representation of the same value in different languages Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 88 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition
203. iner having a round neck of relatively smaller diameter than the body and an opening capable of holding a closure for retention of the contents Specifically a narrow necked container as compared with a jar or wide mouth container The cross section of the bottle may be round oval square oblong or a combination of these Bottles generally are made of glass or plastics but can also be earthenware or metal Bottle may be disposable recyclable returnable or reusable Package Type Blister pack packagingTypeCode BPG Blister pack A type of packaging in which the item is secured between a preformed usually transparent plastic dome or bubble and a paperboard surface or carrier Attachment may be by stapling heat sealing gluing or other means In other instances the blister folds over the product in clam shell fashion to form an enclosing container Blisters are most usually thermoformed from polyvinyl chloride however almost any thermoplastic can be thermoformed into a blister Package Type Brick packagingTypeCode BRI Brick A rectangular shaped stackable package designed primarily for liquids such as juice or milk Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 110 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute De
204. inicalSizeType WEI GHT Temporary GDSN value pending future GDSN deployment Customer communicationChanne EMAIL eMail Creating sending receiving of unstructured free Contact Email ICode text messages or documents using computer network a mini computer or an attached modem and regular telephone line or other electronic transmission media Customer communicationChanne TELEPHONE Telephone Voice data transmission by telephone Contact Phone ICode Over the consumerSalesConditi OTC Over the Counter products that may be sold Counter OTC onCode without a prescription These products are generally available without restrictions Prescription Use Rx consumerSalesConditi onCode PRESCRI PTION_REQUI RED Trade item may only be sold or dispensed under the direction of a prescription N A contactTypeCode CXC Consumer Support The party which provides product support to the GS1 Code end user of a trade item or a service GS1 Code Combination groupedProduct COMBI NATION Product Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 97 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where Definition Kit Kit and Combination Product groupedProduct groupedProduct KIT KIT
205. inuation of a Package DI package is directly Number related to the and discontinuation of the Commercia primary DI of the base package Distributio However a package n End Date can also be are discontinued without entered the discontinuation of must also the base package enter Package Discontinu e Date Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 41 of 218 Data Element Description Data Entry Notes Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Package Indicates whether the package is in Auto populated based NA data element is Auto NA In Commercial NO Public Status commercial distribution as defined on Package not able to be changed Populated Distribution under 21 CFR 807 3 b Discontinue Date If directly most are Not in Package DI and auto populated fields Commercial related elements are whose information Distribution entered and no depends on another Package Distribution data element End Date is entered the status is In Commercial Distribution Customer Contact Customer Phone number for the support Enter 10 digit North Can edit add or delete 1 Numeric N A NO Public Contact contact American
206. ion humidity attribute labels on the Storage and Handling Type tab Corrections to the sheet Updated code lists with missing values Additional Classification Code List Corrections to the sheet Updated the name of the FDA Premarket Submission Number in the FDA GUDID Column on the additional trade item classification agency tab Enter comment about name and definition changes being requested in GDSN Change the attribute used for the FDA GUDID Publish date from effectiveDate to be fDAGUDI DPublishDate AVP and a final trading partner dependent deployment of uDI DPublishDate Updated the GDSN Notes for the GMDN Preferred Term and Definition attributes Corrections to the sheet Corrected the MRI Compatibility codes to be all capitals Corrections to the sheet Updated the guidance on the use of the Sterility codes Added code value of KIT_AND_COMBINATION to denote a TRUE value for both TRUE and COMBINATION Corrections to the sheet Corrected GDSN Definitions for the additionalClassificaitonAgency which incorrectly only referenced Premarket Authorization Numbers Corrected truncated definitions in the packaging type code list Corrected the MRI Compatibility code for the GDSN from MRI_CONDITIONAL to the correct value from the GDSN Schema of MRI_ COMPATIBLE Corrected missing words in the FDA Required column foe Supplement Number to complete phrase to state Not Required for Kits Updated guidance on
207. ion regarding the applicant s legal right to market a medical device for the following submission types 510 k PMA PDP HDE BLA and NDA Product Code additionalTradel temCl assificationCode 43 US FDA PCCD US FDA Product Code Classification Database The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health CDRH in support of its mission This database contains device names and their associated product codes The name and product code identify the generic category of a device for FDA The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862 892 SPL Name FDA Preferred Term Code additionalTradel temCl assificationCode 65 FDA Preferred Term Code FDA Preferred Term Code Unique four character value assigned by the FDA to indicate a GMDN Preferred Term without exposing the GMDN PT Code FDA Medical Device Listing Number additionalTradel temCl assificationCode CODE PENDING Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 93 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable D
208. ionEnvironm Float The minimum atmospheric AVP transportationEnviro SPL Name entAtmosphericPressMi pressure in which the item transportationEnvir nmentAtmosphericP Storage and n should be transported to onmentAtmospheri ressureMinimum Handling Low remain usable This value is cPressureMinimum Value the value below which the trade item should not be subjected Unit of AVP transportationEnvironm Float The minimum atmospheric AVP transportationEnviro Measure SPL entAtmosphericPressMi pressure in which the item transportationEnvir nmentAtmosphericP Name n should be transported to onmentAtmospheri ressureMinimum Storage and remain usable This value is cPressureMinimum Handling Unit the value below which the of Measure trade item should not be subjected Storage and Tradeltem Attribute humidityQualifierCode Code Code qualifying the type of a transportationHumid Handling Humidity temperature for example ityMaximum Type nformatio STORAGE transportationHumid nModule ityMinimum High Value Tradeltem Attribute maximumHumidityPerc Decimal The maximum humidity in transportationHumid SPL Name Humidity entage percentages that the goods ityMaximum Storage and nformatio should be stored in Handling High nModule Value Low Value Tradeltem Attribute minimumHumidityPerce Decimal The maximum humidity in transportationHumid SPL Name Humidity ntage percentages that the goods ityMinimum Storage and nformatio should be stored
209. ip to UDI the data should now be ready for registration in the corresponding UDI database such as the U S FDA GUDID Section two of this document outlines three ways for registering data with the U S FDA s GUDID including how to use a GDSN Data Pool to register the data on behalf of the Brand Owner 4 Audit and Evaluate Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 21 of 218 1 8 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Part of the information lifecycle management includes routine monitoring to ensure the data is fit for purpose This is typically an ongoing process which is part of a continuous data quality management and improvement process It can be in the form of an actual audit event but generally it is part of the user feedback process as a result of application of the information Ideally the Audit is performed against a set of Metrics or Key performance Indicators Error investigation should include a route cause analysis to determine the cause of the problem and steps to prevent it from re occurring Some organisations include a scorecard to report performance and track improvements over time 5 Update and Maintain The information lifecycle management process should include a step to update information as relevant changes occur in any part of the master data This applies to information about the product as well as well as the organisation This step
210. ipients in the GDSN By doing so they will be able to leverage their GDSN connection to register data in future UDI database As mentioned in section 1 3 4 the U S FDA Global UDI database is identified by GLN 1100001017041 within the GDSN Data Pools offering this service This unique identification ensures that there is a single and unique global identification of the U S FDA GUDID within the entire GDSN community for all Data Pools to use in the submission and registration of the Brand Owner s medical device product data Below is a brief overview of options available to labelers for registering their data in the FDA s GUDID 1 Manual data entry via the Web based tool This refers to a web portal provided by the U S FDA to register data directly in their GUDI The portal provides a means for the medical device Brand Owner to enter and update their data manually directly in their database 2 Bulk data registration direct from a Brand Owner s internal application using the HL7 standard This refers to a machine to machine automated method of registering data It requires the use of the Standard Product Labelling standard from HL7 This provides the means for a Brand Owner to Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 23 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline register data directly from an internal application such as an ERP to the GUDID The
211. ired Field with the SPL Text for Package DI Number Contains DI Package Package Discontinue Date Support Contact Phone Support Contact Email Code Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 5 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Size Type Size Value Size Unit of Measure Size Type Text Storage and Handling Type High Value Low Value Unit of Measure Sterilization Method Updated the GUDID Cardinality field with the SPL Text for Device Subject to Direct Marking DM but Exempt DM DI Number Secondary DI Number Package DI Number Contains DI Package Support Contact Phone Support Contact Email Device Exempt from Premarket Submission FDA Premarket Submission Number Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Size Type Size Value Size Unit of Measure Size Type Text High Value Low Value Unit of Measure Special Storage Conditions Sterilization Method Updated the GUDID Data Type field with the SPL Text for Version or Model Number Device Description DI Record Publish Date Note date format is different between the Web Portal and the SPL Message Commercial Distribution End Date Note date format
212. ired Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role hasBatchNumber Datatype Secondary Class Boolean Multiplicity Optional Occurrence Single Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 191 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module PackagingMarkingModule Definition Indication whether the base trade item is batch or lot number requested by law not batch or lot number requested by law but batch or lot number allocated or not batch or lot number allocated A batch or lot number is a manufacturer assigned code used to identify a trade item s trade item on batch or lot Differs from Serial Number which is a manufacturer assigned code during the trade item on cycle to identify a unique trade item Code List Name Population Guidance below This attribute is a Boolean clarifying how the item is controlled It is not for the population of actual lot or batch numbers Neither the GUDID nor GDSN are used to provide actual Batch or Lot numbers These should be communicated in transactional documents such as packaging shipping and invoice documents A value populated of TRUE signifies that the device has as one of its controls a batch or lot number It also signifies that the batch or lot number
213. is different between the Web Portal and the SPL Message Package DI Number Package Discontinue Date Note date format is different between the Web Portal and the SPL Message Support Contact Phone Device Exempt from Premarket Submission Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Storage and Handling Type Unit of Measure Updated the GUDID Length field with SPL text for Primary DI Number Unit of Use DI Number DM DI Number Secondary DI Number Package DI Number Contains DI Package Device Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code Exempt from Premarket Submission FDA Premarket Submission Number Supplement Number Product Code MRI Safety Status Storage and Handling Type Unit of Measure Updated the GUDID Values Terminology field with the SPL Text for Device Exempt from Premarket Submission Added updated and deleted codes values for the Clinical Size Type Angle Area SurfaceArea Outer Diameter Pore Size Pressure and Width Corrected some of the tabs which did not update correctly with the information above primarily code list tabs for sterilization and MRI Safety Corrected incorrect GUDID Occurrence notes in column O for Secondary DI attributes Package DI attributes MRI Safety Clinically Relevant Size attributes Storage and Handling attributes
214. itional Trade item Identification Type Code set of attributes This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number Secondary DI Number DM DI Number and FDA Listing Number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but cannot be edited or deleted Code SPL Name GMDN Preferred Term Code and FDA Preferred Term Code FDA GUDID Description GMDN Preferred Term PT Code is a unique five digit code used to identify Data Entry Notes Enter all applicable GMDN Preferred Term Codes or FDA PT Codes Each device common device types This PT Code is assigned to medical devices and related health care products for the purposes of grouping and categorization SPL Definition for GMDN Preferred Term PT Code Unique numerical five digit number used to generically identify medical devices and related health care products SPL Definition for FDA Preferred Term Code Unique four character value assigned by the FDA to indicate a GMDN Preferred Term without exposing the GMDN PT Code record must have at least one assigned GMDN Code FDA PT Code DI records are allowed gt 1 GMDN Code FDA PT Code if necessary Must enter GMDN Code OR FDA PT Code please don t ente
215. kagingTypeCode signifies that the item has as one of its controls an expiration date It also signifies that the expiration date will be printed on the packaging and be contained in the UDI 6 45 Donation Identification Number FDA GUDID Description Indicates the device is managed by a Donation Identification Number This number can be found on the device label or packaging The Donation Identification Number is applicable to devices that are also regulated as HCT Ps and is a number that is assigned to each donation Data Entry Notes Choose Yes No from the drop down list This PI is only applicable to HCT P products regulated as medical devices Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Required Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 194 of 218 Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Indicates the device is managed by a Donation Identification Number This number can be found on the device label or packaging The Donation Identification Number is applicable to devices that are also regulated as HCT Ps and is a number that is assigned to each donation Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public
216. l of a change in a medical device with an approved PMA HDE or PDP Enter all valid Supplement Numbers Each DI record represents a version or model of a device For each DI record you must submit the original premarket authorization number and the supplement number through which you obtained approval for the version or model identified in that DI record as required by 830 310 b 11 Alth ough not all PMA supplements are applicable to a given model or version if FDA approves a subsequent supplement applicable to that version or model the GUDID DI record must be updated with that supplement number in accordance with 21 CFR 830 330 b 30 day notice supplements should be submitted ONLY if the 30 day notice impacts the device design specifications or performance of the finished devices Do not enter alpha Add Addition of new data is allowed Conditional ly Required Premarke t Submissio n Number OR exempt status fulfills regulatory requireme nt Type Num Length CDRH 1 3 digits CBER 1 4 digits NA NO Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 47 of 218 Data Element Description Data Entry Notes characters Example Supplement 4 should be entered as 004 Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New
217. lSizeType CATHETER_GAUGE Temporary GDSN value pending future GDSN Formerly French deployment Catheter Gauge Size Type Height clinicalSizeType HEI GHT Temporary GDSN value pending future GDSN deployment Size Type Length clinicalSizeType LENGTH Temporary GDSN value pending future GDSN deployment Size Type Lumen lInner Diameter clinicalSizeType LUMEN_INNER_DIAMETER Temporary GDSN value pending future GDSN formerly Lumen deployment Diameter Size Type Needle Gauge clinicalSizeType NEEDLE_GAUGE Temporary GDSN value pending future GDSN deployment Size Type Outer Diameter clinicalSizeType OUTER_DIAMETER Temporary GDSN value pending future GDSN deployment Size Type Pore size clinicalSizeType PORE_SIZE Temporary GDSN value pending future GDSN deployment Size Type Pressure clinicalSizeType PRESSURE Temporary GDSN value pending future GDSN deployment Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 96 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Size Type Total Volume clinicalSizeType TOTAL_VOLUME Temporary GDSN value pending future GDSN deployment Size Type Width clinicalSizeType WIDTH Temporary GDSN value pending future GDSN deployment Size Type Weight cl
218. lass Integer Multiplicity Optional Occurrence Single Definition The count of medical devices which are contained inside the base item for regulatory purposes Code List Name N A Population Guidance below Device count is anumber It is important to note that if the Device Count is greater than 1 gt 1 then a Unit of Use DI is required to be provided in the GUDID Relevant examples of how to populate are Pack of 6 syringes where the pack is the device Primary DI In this example uDIDDeviceCount would be populated with 6 for a device count of 6 An assay with 5 tests where the Assay is the device Primary DI In this example uDIDDeviceCount would be populated with 1 for a device count of 1 The assay can not be split apart however netContent for GDS Recipients could be 5 Z52 signifying 5 uses Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 6 4 Unit of Use DI Number FDA GUDID Description An identifier assigned to an individual medical device when a UDI is not Data Entry Notes Enter the Unit of Use DI Number labeled on the individual device at the level of its unit of use Its purpose is to associate the use of a device to on a patient Unit of Use DI is an identifier used by hospital staff and Materials Manageme
219. le for surfaces It has the benefit of being able to oxidize most organic matter It is a toxic and unstable gas that must be produced on site so it is not practical to use in many settings Device TRUE initialManufacturerSter PERACETIC_ACI D A chemical in the organic peroxide family It is a Packaged as ilisationCode bright colorless liquid with a characteristic acrid Sterile acetic acid type odor It has a strong oxidizing potential is highly corrosive and can explode at temperatures exceeding 110 C Device TRUE initialManufacturerSter BETA_RADIATION Beta particles are able to penetrate living matter to Packaged as ilisationCode a certain extent radiation intensity from a small Sterile source of radioactive material decreases as one over the distance squared and can change the structure of struck molecules Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 101 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Device TRUE initialManufacturerSter GAMMA_RADIATION Gamma rays are very penetrating and are Packaged as ilisationCode commonly used for sterilisation of disposable Sterile medical equipment such as syringes needles cannulas and IV sets Gamma radiation r
220. ls will populate the numeric value in the GUDID attribute Value and the UoM qualifier in the GUDID attribute Unit of Measure For example for a 16 gauge needle the value is 16 and the UoM is H79 for a 20 cc syringe the value is 20 and the UoM is CQM This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but cannot be edited or deleted 6 54 Size Type Text SPL Name Size Text FDA GUDID Description Additional undefined device size not represented in the GUDID Size Type LOV Data Entry Notes Enter Size Type Size Unit and Unit of Measure for each entry Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required Required if Size Text specify is selected above Data Type amp Length Type Alphanum Length 200 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Module AVP Content Attribute Role clinicalSizeText actual AVP name ends in 1 2 3 or 4 to allow grouping of AVP attributes Datatype Secondary Class String Multiplicity Optional Occurrence Single Release 2 0 Ratified Oct 2015 2015 GS1 AIS
221. m UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM Pressure PENDING Currently no GDSN or UN Recommendation 20 Value for FDA GUDID UoM A Question is posed to the FDA to clarify which volume they refer to or does it matter If it does not matter UN Recommendation 20 has the following to be used and a GDSN Change request would be entered to support NA M1 C12 H63 MF MK GO Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 132 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Pressure U L Units per Liter storageEnvironmentA Pressure PENDING Currently no GDSN or Units of tmosphericPressureM UN Recommendation Measure aximum UoM 20 Value for FDA Pressure storageEnvironmentA GUDID UoM A tmosphericPressureMi Question is posed to nimum UoM the FDA to clarify transportationEnviron which unit they refer mentAtmosphericPres to sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Pressure ug TotalVolume storageEnvironmentA Pressure PENDING Currently no GDSN or Units of Measure Pressure Microgram per Total Volume tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi
222. mation to the GUDID the GDSN attribute humidityQualifierCode is in a repeatable group of attributes which include minimumHumidityPercentage and maximumHumidityPercentage Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Humidity will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Humidity will be provided The GDSN attributes correlating to the GUDID attributes for atmospheric pressure are temporary attributes AVP in GDSN They will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attributes are in two pairs One pair is for the GUDID storage pressure attributes storageEnvironmentAtmosphericPressureMinimum and storageEnvironmentAtmosphericPressureMaximum The other pair is for the GUDID transportation pressure transportationEnvironmentAtmosphericPressMin and transportationEnvironmentAtmosphericPressMax The applicable storage type can be derived from the attribute name The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes for pressure GUDID Storage Type Code GDSN Attributes Storage environment atmospheric storageEnvironmentAtmosphericPressureMaximum AVP pressure storageEnvironmentAtmosphericPressureMinimum Handling environment transportationEnvironmen
223. ment should consult with their GDSN Certified Data Pool for the exact naming convention and message formatting applicable to the contract between the user and the Data Pool Figure 4 1 GDSN to GUDID Attribute Table legend Header Definition FDA GUDID Data Element The name of the element being requested Module The name of the higher level grouping of classes and attributes Modules group together similar attributes or attributes which describe or define certain information Content This is a textual term used to provide a high level grouping of what the row is describing for example Attribute Association etc Attribute Role The name of the attribute as listed in the GS1 Global Data Dictionary GDD for use with GDSN v3 1 Datatype Secondary Class The type of value for the element Boolean Text Code List etc including how many characters are available for population This may also be the name of a class or group attributes to which are referenced for use at this point in the message Definition Text defining the element Code List Name When the attribute is of a Data Type called Code List there is a specified list of Code Values Valid Values from which the attribute must be populated This is the name of the code list which has the relevant values GDSN Notes Any brief guidance or implementation notes applicable to the row GDSN v2 8 Attribute Name The nam
224. mmediately childGTIN for the Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 70 of 218 FDA GUDID Module Data Element Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Quantity per Corel tem Package Attribute quantityOfNextLowerLe velTradeltem nonNegativel ntege A The number of one child trade item as identified by the association of ChildTradeltem class to Tradel teml dentification class contained by the parent trade item The child trade item must be in the hierarchy level immediately below the parent trade item quantityOfNextLowe rLevelTradel tem N A Packaging Informatio nModule Package Type Attribute packagingTypeCode Code The dominant means used to transport store handle or display the trade item as defined by the data source This packaging is not used to describe any manufacturing process Data recipients can use this data for Space Planning Data Accuracy Tolerances Supply Chain processes Recycling process In combination with packaging materials e Product buying procurement decisions Tax calculations fees duties calculation LOGI CAL POPULATION Logical Population by Data Pools based on the Packaging Type Code value populated Only the descri
225. mp Length Type Alphanum Length 7 Entry List of Values LOV N A New DI Trigger NO Public Private Status Private GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role fDAMedicalDeviceListing Datatype Secondary Class String Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 186 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline AVP Module Multiplicity Optional Occurrence Multiple Definition Most Owners or operators of places of business also called establishments or facilities Code List Name N A that are involved in the production and distribution of medical devices intended for use in the United States U S are required to list the devices that are made at their facility and the activities that are performed on those devices Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments Knowing where devices are made increases the nation s ability to prepare for and respond to public health emergencies 6 37 Population Guidance below This attribute has a temporary attribute AVP in GDSN fDAMedicalDeviceListingNumber The GUDID is asking for the FPD Medical Device Listing number assigned to the device It will be deployed into the GDSN Schema in 2016 17 into a final solution in the Add
226. n A trade item in the item hierarchy level immediately below the parent trade item Code List Name N A Population Guidance below The GUDID Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package m Package Type m Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references a GTIN in the hierarchy above the primary DI This would be or is one of the parent s of the primary DI These parents are identified by their own GTIN and GDSN Message They are linked together through the use of the parent child relationship Population of the GUDID values for the package information will be based on any value populated in the GDSN attribute tradeltemUnitDescriptor with the exception of BASE _UNIT_OR_EACH The GTIN with a tradeltemUnitDescriptor value of BASE_UNIT_OR_EACH will always be a Primary DI for the GUDID See the examples below In GDSN the following is provided Hierarchy Number 1 globalTradeitemNu mber tradeltemUnitDescriptor mber ChildTradeltem gl obalTradeltemNu tem quantityofNextL owerLevelTradel 2061414111111c CASE 1061414111111c 5 5 cartons in a case 1061414111111
227. n Number and its associate Supplement Numbers Corrected the name of the Additional Classification header on the Additional Classification Agency code list tab to be Additional Classification Agency Name 6 01 Jul 2014 Pete Alvarez Replaced the GS1 DataMatrix example in section 1 3 3 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 11 of 218 Release Release 1 2 Draft 1 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Date of Change 15 Jul 2014 Changed By John Ryu Summary of Change Incorporate WR 14 103 and 14 111 WR 14 103 Corrections to the sheet Updated the GDSN note for the Labeler DUNS number Brand Owner GLN is a GDSN Mandatory field and the additional Party Identification attributes will be linked to the Brand Owner GLN specifically Change the approach for the FDA Device Count A new GDSN attribute has been requested and this value will no longer be derived from the attribute netContent An AVP has been put in place to support this until full GDSN deployment netContent will be moved from the FDA GUDI D Mapping area to the supply chain area at the bottom of the spreadsheet Updated the FDA Attribute name for the DI Publish Date the Discontinue Date which were missing the format WR 14 111 Corrections to the sheet Added several AVPs to support new sterilization methods until GDSN can deploy the codes isl ni
228. nEnvironmentAtmosphericPressMax The applicable storage type can be derived from the attribute name The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes for pressure GUDID Storage Type Code GDSN Attributes Storage environment atmospheric storageEnvironmentAtmosphericPressureMaximum AVP pressure storageEnvironmentAtmosphericPressureMinimum Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 206 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GUDID Storage Type Code GDSN Attributes Handling environment transportationEnvironmentAtmosphericPressMaximum AVP atmospheric pressure transportationEnvironmentAtmosphericPressMinimum For the GUDID the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and others have a single or recommended value Population of all possibilities can be handled in the GDSN and the GUDID using the following chart Information Type Available Range of Lowest to Highest Less Than a Value Populated In Minimum or Low Values Field Value Lowest Value Maximum or Hi
229. nagement refers to processes and procedures within an enterprise related to lifecycle information management In relationship to UDI regulation this refers to product master data and lifecycle management of the related information The U S FDA regulation contains specific data management requirements and recommendations to which a Brand Owner must adhere However this section contains general guidance as a recommendation to augment the requirements of any regulator In case of conflict the regulation supersedes this guidance Below are seven basic steps of an information lifecycle management process 1 Create Import or Receive The first step is the creation of the product data This may include gathering information related to the product specifications raw materials function regulatory requirements and sterilization among other areas The U S FDA GUDID includes a specific list of data requirements and data relationship based on the recommendation from the International Medical Device Regulators Forum IMDRF formerly known as the Global Harmonization Task Force plus additional information required by the U S FDA In this step the Brand Owner should confirm the core attributes and match against data requirements of the UDI regulation Sections 3 and 4 of this document contain a listing of the GUDID data requirements and cross reference to GDSN attributes The U S FDA UDI rule and Users Guide supersedes any information found in this document
230. nd Date is entered the status is In Commercial Distribution Edit Rules After Grace Period NA data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length N A Entry List of Values LOV In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role Derived by the FDA GUDID based on the Package DI s discontinuedDateTime Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below If the current date is equal to or greater than the GUDID Publication Date effectiveDate in GDSN of the Primary DI then the Package Status will be set to In Commercial Distribution automatically by the FDA If the current date is equal to or greater than the GUDID Package Discontinue Date discontinuedDateTime for the package level GTIN in GDSN then the Package Status will be set to Not in Commercial Distribution automatically by the FDA Note if the Commercial Distribution Status of the Primary DI is set to Not in Commercial Distribution the Package Status will also be set to Not in Commercial Distribution 6 26 Customer Contact Phone FDA GUDID Description Phone number for the customer contact
231. ndent of each other this element is designed to capture information about the device before it can safely encounter a patient regardless of whether the device is single use or reused after reprocessing These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler If answered Yes at least one Sterilization Method below must be selected None NO edit add or delete are allowed Required Type Boolean Yes No YES Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 63 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Sterilizatio n Method Indicates the method s of sterilization that can be used for this device Release 2 0 Ratified Oct 2015 Choose a value from the drop down LOV Only applicable if the answer to Requires Sterilization Prior to Use is Yes otherwise the LOV will remain inactive The Entry LOVs represent the sterilization methods recognized by the CDRH Infection Control Branch Methods selected should be only those approved for each device by the CDRH Office of Device Evaluation Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed 2015 GS1 AISBL Conditional ly Required
232. ndicates there are 10 eaches in the pack 4061414111111c 2 3061414111111c Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be deleted 6 21 FDA GUDI D Description Quantity per package The number of packages with a unique primary DI within a given packaging configuration Data Entry Notes Enter the number of devices per package The quantity of a package configuration must be gt 1 Examples Package Carton Pkg DI 201 contains 4 boxes of DI 101 the quantity per package is 4 Package Case Pkg DI 301 contains 5 cartons of Pkg DI 201 the quantity per package is 5 Package Carton Pkg DI 202 contains 10 boxes of DI 101 the quantity per package is 10 Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required f Package DI is entered Data Type amp Length Type Num Length 9 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module Core Item Content Attribute Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 168 of 218 Module Core Item Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Attribute Role quantityOfNextLower
233. ng of entered js subject Marking DM but data is allowed to 801 45 Exempt only if the device 1 is intended to be used more than once and 2 is intended to be reprocessed before each use but also 3 meets any one of the exception criteria outlined under 21 CFR 801 45 d If the device is not required to be directly marked under 21 CFR 801 45 a then this box should not be checked DM DI Indicates that the DM DI Number is Select checkbox if Add Addition of new Conditional Type NA NO Public Different different than the Primary DI appropriate data is allowed ly Boolean from Number Delete Deletion of Required Primary entered data is DI allowed If device Edit Editing of entered is subject data is allowed to 801 45 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 35 of 218 Data Element Description Data Entry Notes Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger R Public Private Status Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline DM DI An identifier that is marked directly Enter Direct Marking Add Addition of new Type NA NO Public Number on the medical device and is DI Number Must be data is allowed Conditional Num or different than the Primary DI from
234. nimum UoM transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UN Recommendation 20 Value for FDA GUDID UoM A Question is posed to the FDA to clarify which volume trey refer to or does it matter If it does not matter UN Recommendation 20 has the following to be used and a GDSN Change request would be entered to support GQ H29 J33 J34 J35 MC Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 133 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Handling Environment Atmospheric Pressure eratureMaximum UoM storageHandlingTemp eratureMinimum UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing and Handling Fahrenheit eratureMaximum point of water is 32 degrees Fahrenheit F and Units of UoM the boiling point 212 F at standard atmospheric Measure storageHandlingTemp pressure placing the boiling and freezing points of Handling eratureMinimum water exactly 180
235. nmentAtmosphericPressureMaximum Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum pressure at which the trade item can be stored and handled This uses a measurement consisting of a unit of measure and a value Code List Name Module Content Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 213 of 218 Module Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline AVP trasnportationEnvironmentAtmosphericPressMax Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected Code List Name Population Guidance below This GUDID attribute will have several different mappings from GDSN based on the needed piece of information To provide Temperature information to the GUDID the GDSN attribute teperatureQualifierCode is in a repeatable group of attributes which include minimumTemperature maximumTemperature and temperatureMeasurementUnitCode Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Temperature will be provided For
236. nt to account for a single device when the UDI is labeled on a higher level of packaging The Unit of Use DI does not appear on the label Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters If Device Count 1 cannot add Unit of Use DI Number Edit Rules After Grace Period Edit Editing of entered data is allowed Required Conditionally Required If Device Count gt 1 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 149 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description An identifier assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use Its purpose is to associate the use of a device to on a patient Data Type amp Length Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN requires 2 GDSN attribute to denote the GUDID Unit of Use Module Core Item Content Attribute Attribute Role componentNumber Datatype Secondary Class nonNegative I nteger Multiplicity Mandatory If module is invoked Occurrence Single Definition Indic
237. ntegrated plastic into the RIBC The container is used for the transport and storage of fluids and other bulk materials The Package Type Aerosol packagingTypeCode AE Aerosol A gas tight pressure resistant container with a valve and propellant When the valve is opened propellant forces the product from the container in a fine or coarse spray pattern or stream e g a spray can dispensing paint furniture polish etc under pressure It does not include atomizers because atomizers do not rely on a pressurised container to propel product from the container Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 108 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Description where applicable GS1 GDSN Code Value Definition Package Type Ampoule packagingTypeCode AM Ampoule A relatively small container made from glass or plastic tubing the end of which is drawn into a stem and closed by fusion after filling The bottom may be flat convex or drawn out An ampule is opened by breaking the stem Package Type Barrel packagingTypeCode BA Barrel A cylindrical packaging whose bottom end is permanently fixed to the body and top end head is either removable or non removable Package Type Bag in Box packagingT
238. nter current FDA Premarket Submission Number s Each DI record represents a version or model of a device For each DI record you must submit the original premarket authorization number and the supplement number through which you obtained approval or clearance for the version or model identified in the DI record as required by 830 310 b 11 FDA Premarket Numbers should be verified with the FDA PMA or 510 k database to make sure the Number represents the subject of the device record Device records should be updated with additional numbers in the future as needed Example PMA 123456 should be entered as P123456 Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Required Conditional ly Required Premarke t Submissio n Number OR exempt status fulfills regulatory requireme nt Data Type amp Length Type Alphanum Length 8 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 46 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Suppleme nt Number Number assigned by FDA to a supplemental application for approva
239. number after Grace Period Required if 20 10 Phone For international support SPL Definition Phone number for heal sea eae es SPL Text the Customer contact to be used by the use of or but nis Alphanum patients and consumers for device can enter these entered eric related questions symbols SPL Text II Conditional ly Required ONLY required if Customer Contact Phone is entered Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 42 of 218 Data Element Customer Contact Email Description Email for the Customer contact to be used by patients and consumers for device related questions Data Entry Notes Enter email address This email address could be the same one that appears on the device labeling or the company website Labelers can identify a Customer Contact email and a Customer Contact phone number for each device record If a phone number is entered and you don t have a Customer Contact email please enter XX XX XX Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditional ly Required ONLY required if Customer Contact Email is en
240. o 21 CFR 801 3 a package is defined as a fixed quantity of a particular version or model of a device Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 38 of 218 Data Element Package DI Number Description A device identifier for the package configuration that contains multiple units of the base package does not include shipping containers Data Entry Notes Enter Package DI Number Must be from same Issuing Agency as Primary DI Data type and field length are determined by the individual Issuing Agency structure GS1 Numeric Num with 14 digits HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Examples Box of Gloves DI 101 4 Boxes of Gloves DI 101 in a Carton Package DI 201 the UDI on the Carton 5 Cartons Pkg DI 201 in a Case Package DI 301 the UDI on the Case 10 Boxes of Gloves DI 101 in a Carton Package DI 202 the UDI on the Carton Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Required Conditional ly Required If device is available in higher levels of packaging Data Type amp Length Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV NA New DI Trigger R NO Public Private Status Public
241. o data chemically or otherwise combined or Do not check if the is mixed and produced as a single device is a provided entity packaged together as a single constituent part of a No is package or packaged separately for combination product stored the intended use together as defined under 21 CFR 3 2 e At least one of the products in the combination product must be a device in this case Premarket Device Device is exempt from FDA Select checkbox if None NO edit add or Conditional Type NA NO Public Exempt Premarket regulations or a FDA has by delete are allowed ly Boolean from preamendment device regulation exempted Required Premarket this device from i i eee SPL Definition FDA Premarket sities t Premark submission is not required for this requirements or for Submissio device preamendment n Number devices that are not OR exempt subject to premarket status submission fulfills requirements regulatory requireme If left unselected a nt No is stored and a Premarket Submission Number should be entered below Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 45 of 218 Data Element FDA Premarket Submissio n Number Description Number associated with the regulatory decision regarding the applicant s legal right to market a medical device for the following submission types 510 k PMA PDP HDE BLA and NDA Data Entry Notes E
242. o the Global Product Classification GPC Code List Name N A Population Guidance below This set of attributes will allow for the population of a Pre Market Submission Number for the device This number will correlate to the scientific and regulatory review information which was created to evaluate the safety and efficacy of the device This set of attributes is required to be provided when the value populated for the GDSN attribute exemptFromFDAPreMarketAuthorization is not TRUE This set of attributes will also be used to populate several pieces of information FDA Product Code FDA Preferred Term Code and GMDN For supply chain use this set of attributes can also provide the UNSPSC code for the device If there is a Supplement Number place a colon after the FDA Premarket Submission Number then add the Submission Number Repeat these attributes and process for all applicable FDA Premarket Submission Numbers and Supplement Numbers For example a device has a FDA Premarket Submission number of P369258 Over time 3 Supplements have been filed and approved 001 002 and 004 Population of this information would look like this AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P369258 001 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P369258 002 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P
243. ocess for all applicable FDA Premarket Submission Numbers and Supplement Numbers For example a device has a FDA Premarket Submission number of P369258 Over time 3 Supplements have been filed and approved 001 002 and 004 Population of this information would look like this AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P369258 001 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P369258 002 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P369258 004 For example a device has a FDA Premarket Submission Number of P147025 Over time 2 Supplements have been filed and approved 001 002 Then a second FDA Premarket Submission Number was obtained P963074 and a subsequent Supplement was filed and approved 001 Population of this information would look like this AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P147025 001 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P147025 002 AdditionalTradeltemClassificationSystemCode 58 additionalClassificationCategoryCode P9630074 001 The Data Pool will parse the supplement number from the FDA Premarket Submission Number and provide to the FDA GUDID in the two fields as required by the FDA Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day
244. ocument nor does it make a commitment to update the information contained herein GS1 and the GS1 logo are registered trademarks of GS1 AISBL Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 15 of 218 a uu A W N Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Table of Contents LMEFOGUCEION Sisiicicisccccnmcsnnisncaniidinees aaa a aaan LO 1 1 P rpose of this DOCUMENE sracrornriierier naan aE AE A E AT E A A 18 1 2 Who Will Use this DOCUMEN 0 0 nanna A E EE ATE TEETE 18 1 3 PrereqQuiSite seruron a OEA OE T ee wanes ee E 18 1 3 1 The GS1 Global Company Prefix GCP ssssssssssrseerrssssrrrrrrssrrrrrrrrrsrrrnrrrnnrnnnnrrnnnnn 18 1 3 2 Role of the Global Trade Item Number GTIN and Application Identifiers Als 18 1 3 3 Automatic Identification and Data Capture AIDC Marking sssssssssssissrsssrsrrssrrrresrrsrs 19 1 3 4 The role of Global Location Number GLN in UDl sssssssrrrsrrrririrrrrnrurnrenesenrrrrnrrrrrena 19 153 5 GDSN KNOWledg ey caneiros i fin that ens arGeaaeehnatin cis Lee tein en aes 19 1 4 What is UDI and G UDID 23 cesciiieisatigatatietiecaceidddeslt haciiisacic inde E eee eine eaedeneia 19 1 5 Master Data Management and Governance ce cece ee eee eee 20 1 6 BEIRO METIR AEEA T A E A air aenen tt ktuanmanelaniasntes E T 20 1 7 Data M nagemMeENt orsirororsstinn eni sni PEET EON PENES E E AE death diese UT E
245. ode List Name N A 6 28 Population Guidance below The GDSN attribute contactType signifies which type of contact information is being provided The GDSN attributes communicationChannelCode and communicationChannelValue can repeat as a pair of attributes for a single contactType There can be more than one contactType populated for a single Trade item For the GUDID the contactType of CONSUMER_SUPPORT will signify the information to be provided to the GUDID via GDSN Where an instance of the GDSN attribute communicationChannelCode is populated with the value of TELEPHONE the corresponding communicationChannelValue will map to the GUDID attribute Customer Contact Phone This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Customer Contact Phone and Customer Contact Email Human Cell Tissue or Cellular or Tissue Based Product HCT P FDA GUDID Description Indicates that the product contains or consists of human cells or tissues that Data Entry Notes Data Entry Notes Select checkbox if DI record is for a product defined under are intended for implantation transplantation infusion or transfer into a human recipient as defined under 21 CFR 1271 3 21 CFR 1271 3 If checked the labeler must assign and label each HCT P device with a distinct identification code per 21 CFR 1271 290 c The di
246. on for a Tradeltem Code List Name N A Population Guidance below This is one of the key elements in GDSN and is required for the use of GDSN By using GDSN to provide data to the GUDID the lowest level GTIN will always be the Primary DI All other issuing agency identification will be published as secondary device identifiers Once published a 7 day grace period begins During the grace period most attribute can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 6 3 Device Count FDA GUDI D Description Number of medical devices in the base package Data Entry Notes Enter the number of devices Example Base Package Box of 100 gloves Primary DI 101 Device Count 100 Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 148 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description Number of medical devices in the base package Data Type amp Length Type Num Length 7 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role uDI DDeviceCount Datatype Secondary C
247. onalTradeltemClassificationCodeListCode 58 Module TradeltemClassification Content Attribute Attribute Role Datatype Secondary Class additionalTradeltemClassificationCode AdditionalTradel temClassificationCode Multiplicity Optional Occurrence Multiple Definition Category code based on alternate classification schema chosen in addition to the Global Product Classification GPC Code List Name N A Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 183 of 218 6 34 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidance below This set of attributes will allow for the population of a Pre Market Submission Number for the device This number will correlate to the scientific and regulatory review information which was created to evaluate the safety and efficacy of the device This set of attributes is required to be provided when the value populated for the GDSN attribute exemptFromFDAPreMarketAuthorization is not TRUE This set of attributes will also be used to populate several pieces of information FDA Product Code FDA Preferred Term Code and GMDN For supply chain use this set of attributes can also provide the UNSPSC code for the device If there is a Supplement Number place a colon after the FDA Premarket Submission Number then add the Submission Number Repeat these attributes and pr
248. oot is an area of a square whose sides are exactly 1 foot in length A square inch is an area of a square whose sides are exactly 1 inch in length Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 118 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Area Units cm2 Square netContent Area CMK Square centimetre A square centimetre is an area of a square whose of Measure centimeter sides are exactly 1 centimetre in length Area Surface Area UoM Area Units m2 Square meter netContent Area MTK Square metre A square metre is an area of a square whose sides of Measure are exactly 1 metre in length Area Surface Area UoM Area Units mm2 Square netContent Area MMK Square millimetre A square millimetre is an area of a square whose of Measure millimeter sides are exactly 1 millimetre in length Area Surface Area UoM Gauge Ch French clinicalSizeValue Dimension H79 French gauge The French scale most correctly abbreviated as Fr French Units of height width depth but also often abbreviated as FR or F is commonly Measure and netContent used to measure the catheter size Circumference Catheter is in millimeters in which 1 Fr 0 33 mm in Gauge diameter In the French Gau
249. opulated in the GUDID Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited 6 60 FDA GUDID Description Requires Sterilization Prior to Use Indicates that the device requires sterilization prior to use Data Entry Notes Choose Yes No from the drop down list The two Sterilization Method questions are independent of each other this element is designed to capture information about the device before it can safely encounter a patient regardless of whether the device is single use or reused after reprocessing These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler If answered Yes at least one Sterilization Method below must be selected Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Module MedicalDeviceTradeltemModule Content Attribute Attribute Role initialSterilisationPriorToUseCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition This is an indication of the type s of sterilisation that is required to
250. or medical devices All other values should not be accepted for a GDSN Target Market value of 840 US Application of the value is based upon whether a mark exists on the packaging as to latex being contained in the device or its packaging If a mark is required to be on the package this attribute is populated with TRUE If no mark is required then this attribute is populated with FALSE This is based on Target Market regulation such as in the US which basically states that if there is latex present a label mark must be placed on the packaging If there is not any Target Market regulations the values of NOT_APPLICABLE and UNSPECIFIED may be used In this case the value of UNSPECIFIED will signify that the submitter of the GDSN Message is uncertain and may not have tested the device for latex content Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited Device labeled as Not made with natural rubber latex FDA GUDID Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information Only applicable to devices not subject to the requirements under 21 CFR 801 437 Not all medical products that are NOT made with natural rubber
251. or recommended value Population of all possibilities can be handled in the GDSN and the GUDID using the following chart Information Type Available Range of Lowest to Highest Less Than a Value Populated In Minimum or Low Values Field Value Lowest Value Minimum or Low Values Field Highest Value Maximum or High Values Field Leave Null provide no value Maximum or High Values Field Highest Value Greater Than a Value Single or Recommended Value Minimum or Low Values Field Lowest Value Maximum or High Values Field Minimum or Low Values Field Maximum or High Values Field Leave Null provide no value Single Same Value populated in both fields 6 58 Unit of Measure SPL Name Storage and Handling Unit of Measure FDA GUDI D Description Data Entry Notes The unit of measure associated with the storage and handling conditions Choose a value from the drop down LOV Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required Required if Storage and Handling Type is added to the device record Data Type amp Length NA Entry List of Values LOV Degrees Celsius Degrees Fahrenheit Degrees Kelvin Kilo Pascal Percent Relative Humidity Millibar New DI Trigger NO
252. orageEnvironment Handling mosphericPressureMaxi which the trade item can be storageEnvironmen AtmosphericPressur Type mum stored and handled This tAtmosphericPress eMaximum uses a measurement ureMaximum storageEnvironment consisting of a unit of AtmosphericPressur measure and a value eMinimum Storage and AVP storageEnvironmentAt Measurement The minimum pressure at AVP storageEnvironment Handling mosphericPressureMini which the trade item can be storageEnvironmen AtmosphericPressur Type mum stored and handled This tAtmosphericPress eMaximum uses a measurement consisting of a unit of measure and a value ureMinimum storageEnvironment AtmosphericPressur eMinimum Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 84 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name High Value AVP storageEnvironmentAt Measurement The maximum pressure at AVP storageEnvironment SPL Name mosphericPressureMaxi which the trade item can be storageEnvironmen AtmosphericPressur Storage and mum stored and handled This tAtmosphericPress eMaximum Handling High uses a measurement ureMaximum Value consisting of a unit of measure and a value Unit of AVP storageEnvironmentAt Measur
253. ould be updated with additional numbers in the future as needed Example PMA 123456 should be entered as P123456 Edit Rules After Grace Period Add Addition of new data is allowed Required Conditionally Required Premarket Submission Number OR exempt status fulfills regulatory requirement Data Type amp Length Type Alphanum Length 8 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN requires 2 GDSN attributes to denote the GUDID FDA Premarket Submission Number Module GDSNTradeltemClassification Content Attribute Attribute Role AdditionalTradel temClassificationS ystemCode Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition The Classification System for the Additional Trade Item Classification Code List Name AdditionalTradeltemClassificationCodeListCode 58 Module TradeltemClassification Content Attribute Attribute Role additionalTradel temClassificationCode Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 181 of 218 Module Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline TradeltemClassification Datatype Secondary Class AdditionalTradel temClassificationCode Multiplicity Optional Occurrence Multiple Definition Category code based on alternate classification schema chosen in addition t
254. peatable field e g Style Colour and Fragrance Allows for the representation of the same value in different languages but not for multiple values Code List Name N A Population Guidance below This description is the Labeler s description for the device 6 12 DI Record Publish Date FDA GUDI D Description Indicates the date the DI Record gets published and is available via Public Search Data Entry Notes Choose date from calendar or manually enter date in new format yyyy mm dd This date determines the Grace Period the 7 calendar days start the day after the DI Record Publish Date This date should be set in the future to allow time to ensure accurate data entry We recommend you set this date in the future but 7 days prior to any compliance deadline Drop down is for Webtool only Edit Rules After Grace Period None NO edit add or delete are allowed Required Required Data Type amp Length Type Num date format Length 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role uDI DPublishDate Datatype Secondary Class DateTime Multiplicity Optional Occurrence Single Definition The date upon which the Trade Item can be published by the Unique Device Identifier Database UDID in their public facing systems Until this da
255. ption is provided to the GUDID packagingTypeCode packagingTypeDescr iption Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 71 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Module Content Attribute Role Datatype Definition GDSN Notes GDSN v2 8 Attribute Data Element Secondary Class Name Package Tradeltem Attribute discontinuedDateTime DateTime Communicates the date on discontinuedDate Discontinue Synchroni which the trade item is no Date sationDat longer to be manufactured es Package FDA will populate Status based on the publication date AVP fDAGUDI DPublishD ate or final deployment attribute uDIDPublishDate and the discontinueDate for each package level published In GDSN these will be the inner pack case and pallet levels as applicable Customer Contact N A Tradeltem Attribute contactTypeCode Code The general category of the Value populated for contactType Contactl nf contact party for a trade item the contact ormation for example Purchasing information is the CONSUMER_SUPPO RT Customer Communic Attribute communicationChannel Code Code specifying the type of Value populated for communicationChan Contact ationChan Code communication channel for the support contact nelCode Phone nel example TELEPHONE phone number is TELEPHONE Release 2 0 Ratified Oct 201
256. r this element is designed to capture information about the device as it enters Commercial Distribution These data elements are not designed to capture sterilization procedures executed by the manufacturer or labeler Special Indicates any special storage Enter any other Add Addition of new Conditional Type NA NO Public Storage requirements for the device storage conditions data is allowed ly Alphanum Conditions For devices kept at Delete Deletion of Required gee room temperature or entered data is Length SPL Text Indicates FH o other standard allowed Required 200 a requirements or the conditions input that Edit Editing of entered if Special product information here data is allowed Storage Conditions is selected above Sterilization Method Device Indicates the medical device is free Choose Yes No from None NO edit add or Required Type Yes No YES Public Packaged from viable microorganisms See the drop down list delete are allowed Boolean as Sterile ISO TS 11139 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 62 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Requires Sterilizatio n Prior to Use Indicates that the device requires sterilization prior to use Choose Yes No from the drop down list The two Sterilization Method questions are indepe
257. r both codes for the same GMDN Name and Definition For GMDN Codes Enter only the 5 digit number omit the P For FDA PT Codes Enter the 4 letter code The FDA PT Codes are assigned to each GMDN term used in place of a GMDN Code They enable labelers to assign a GMDN term to their GUDID submission until a GMDN Code can be obtained from the GMDN Agency The FDA PT Codes can be found in the Find FDA PT Code Module on the GUDID website For more information see the GUDID Final Guidance Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 187 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description GMDN Preferred Term PT Code is a unique five digit code used to identify common device types This PT Code is assigned to medical devices and related health care products for the purposes of grouping and categorization SPL Definition for GMDN Preferred Term PT Code Unique numerical five digit number used to generically identify medical devices and related health care products SPL Definition for FDA Preferred Term Code Unique four character value assigned by the FDA to indicate a GMDN Preferred Term without exposing the GMDN PT Code Required Required SPL Text Required
258. rade item s trade item on batch or lot Differs from Serial Number which is a manufacturer assigned code during the trade item on cycle to identify a unique trade item hasBatchNumber Manufacturin g Date Packaging MarkingM odule Attribute tradeltemDateOnPacka gingTypeCode Code Indicates the type of date marked on the packaging for example Best Before Date Use code value PRODUCTION_DAT E isPackageMarkedWit hManufactureDate Serial Number Packaging MarkingM odule Attribute serialNumberLocationC ode Code The location on the item or packaging of a serial number A serial number is a code numeric or alphanumeric assigned to an individual instance of an entity for its lifetime for example a Microscope model AC 2 with serial number 1234568 and microscope mo LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of any value except NOT_MARKED in serialNumberLocati onCode serialNumberLocatio nCode Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 80 of 218 FDA GUDID Data Element Module Content Attribute Role Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class Definition GDSN Notes GDSN v2 8 Attribute Name Expiration Date Packaging MarkingM odule Attribute tradeltemDateOnPacka gingTypeCode Code
259. rature transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Units of Measure Handling Environment Temperature Relative Humidity dityMaximum UoM storageHandlingHumi dityMinimum UoM transportationHumidi tyMaximum UoM and transportationHumidi tyMinimum UoM Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 138 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Storage Environment Atmospheric Pressure eratureMaximum UoM storageHandlingTemp eratureMinimum UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing and Handling Fahrenheit eratureMaximum point of water is 32 degrees Fahrenheit F and Units of UoM the boiling point 212 F at standard atmospheric Measure storageHandlingTemp pressure placing the boiling and freezing
260. rchase in the dd allowed Length 10 marketplace Edit Editing of entered data is allowed Commerci Indicates whether the device is in Auto populated based NA data element is Auto NA In Commercial NO Public al commercial distribution as defined on Commercial not able to be changed Populated Distribution Distributio under 21 CFR 807 3 b Distribution End directly most are Not in n Status Date If no auto populated fields Commercial Commercial whose information Distribution Alternative or Additional dentifiers Direct Marking DM Direct Marking DM data elements only apply to devices subject to 21 CFR 801 45 Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 34 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Device The device is exempt from Direct Select checkbox if Add Addition of new Conditional Type NA NO Public Subject to Marking requirements under 21 CFR appropriate data is allowed ly Boolean Direct 801 45 Delete Deletion of Required Marking Labeler should select entered data is DM but the checkbox Device allowed If device Exempt Subject to Direct Edit Editi
261. re meter Square millimeter For weight Gram Kilogram Microgram Milligram Metric Ton Pound Ton For total volume Centiliter Cubic Inch Cup Deciliter Femtoliter Fluid Ounce Gallon Kiloliter Liter Microliter Milliliter Nanoliter Picoliter NO Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 57 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Size Type Text SPL Name Size Text Additional undefined device size not represented in the GUDID Size Type LOV Enter Size Type Size Unit and Unit of Measure for each entry Add Addition of new data is allowed Conditional ly Required Required if Size Text specify is selected above Type Alphanum Length 200 Pint Quart For gauge French Gauge For angle Degree For pressure Pound per Square Inch millibar KiloPascal Units per Liter Hertz Millibar NA NO Public Storage and Handling Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 58 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Clinically Relevant Size Storage and Handling Type Indicates storage and handling requirements that are required for the device including temperature
262. reMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 141 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Storage Environment Temperature Celsius eratureMaximum UoM storageHandlingTemp eratureMinimum UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Relative Humidity dityMaximum UoM Units of storageHandlingHumi Measure dityMinimum UoM Storage transportationHumidi Environment tyMaximum UoM Humidity and transportationHumidi tyMinimum UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing and Handling Fahrenheit eratureMaximum point of water is 32 degrees Fahrenheit F and Units of UoM the boiling point 212 F at standard atmospheric Measure storageHandlingTemp pressure placing the boiling and freezing points of Storage eratureMinimum water exactly 180 degrees apart Environmen
263. ricPressureMi Environment nimum UoM Temperature transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Relative Humidity dityMaximum UoM Units of storageHandlingHumi Measure dityMinimum UoM Storage transportationHumidi Environment tyMaximum UoM Temperature and transportationHumidi tyMinimum UoM UoM Volume cin_i Cubic Inch netContent Volume INQ Cubic inch A cubic inch is the volume of a cube of side length Units of Measure Total Volume one inch 0 254 m Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 143 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Volume cup_us Cup netContent Volume CU Cup Units of Measure Total Volume UoM Volume foz_us Fluid netContent Volume OZA Fluid ounce US A fluid ounce US is equal to one sixteenth 1 16 Units of Ounce of a US pint or 29 5735295625 millilitres Measure Total Volume UoM Volume gal_us Gallon netContent Volume GLL Gallon US The U S liquid gallon is legally defined as 231
264. riods signifies multiple occurrences repeatability and a number after 2 periods signifies single occurrence non repeatability Data Type amp Length Entry List of Values LOV The type of value for the element Boolean Text Code List etc including how many characters are available for population This is a list of values which can be provided for code list attributes New DI Trigger Indicator signifying if a change to this data element would trigger a new Device Identifier to be created In GS1 Standards this indicates if a new GTIN should be created due to a change in the value for this element Public Private Status Indicator signifying if this element will be posted on the FDA GUDID public facing website PUBLIC or for FDA consumption only PRI VATE Document reference The FDA term GS1 14 digit numeric value is equal to a GTIN The FDA term Primary DI in GS1 speak would be the primary device GTIN or the EACH level of the hierarchy For example a DI 101 is the Primary GTIN and Dis 201 and 301 would be the packaging levels such as Pack or Case Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 26 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Data Description Data Entry Notes Edit Editing of entered New DI data is allowed Rules Required Data Type amp Length Entry List of Values LOV Public Private
265. rking Datatype Secondary Class Boolean Multiplicity Optional Occurrence Single Definition Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the target market Code List Name N A Population Guidance below This value should default to FALSE unless a Labeler has an exemption and specifically changes the flag to TRUE This attribute is only used when a device is required by the FDA to carry a direct mark UDI on the device itself but has been granted an exemption from the FDA The exemption allows the item to not have a direct mark This attribute is a temporary attribute AVP in GDSN It will be deployed into the GDSN Schema in 2016 17 into a final solution 6 16 DPM DI Different from Primary DI FDA GUDID Description Indicates that the DM DI Number is different than the Primary DI Number Data Entry Notes Select checkbox if appropriate Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Conditionally Required If device is subject to 801 45 Data Type amp Length Type Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role LOGICAL POPULATION by the Data Pool based on value populated in another attribute
266. rmined time period Sterilization Liquid Chemical initialSterilisationPrior GLUTERALDEHYDE A colourless liquid with a pungent odour used to Method ToUseCode sterilize medical and dental equipment It is also used for industrial water treatment and as a chemical preservative Glutaraldehyde is an oily liquid at room temperature density 1 06 g mL and miscible with water alcohol and benzene Sterilization Liquid Chemical initialSterilisationPrior LIQUID_CHEMICAL This is a code value for population with the AVP Method ToUseCode attribute extended nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 104 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Value GS1 GDSN Code Description where applicable Definition Sterilization Microwave Radiation initialSterilisationPrior MI CROWAVE_RADIATION This is a code value for population with the AVP Method ToUseCode attribute extendedl nitialSterilisationPriorToUse This value will be added to the SterilisationTypeCode list in a future GDSN release Sterilization Moist Heat or Steam initialSterilisationPrior AUTOCLAVE Autoclave Steam is a method of sterilisation that Method ToUseCode utilises pressure
267. roup Code Name Code Definition UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a and Handling Celsius eratureMaximum temperature scale the freezing point of water is 0 Units of UoM degrees Celsius C and the boiling point 100 C Measure storageHandlingTemp at standard atmospheric pressure placing the Handling eratureMinimum boiling and freezing points of water exactly 100 Environment UoM degrees apart Humidity transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to and Handling eratureMaximum 1 273 16 of the absolute temperature of the triple Units of UoM point of water One kelvin degree is equal to one Measure storageHandlingTemp Celsius degree Handling eratureMinimum Environment UoM Humidity transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling Units of Measure Handling Environment Humidity tmosphericPressureM aximum UoM storageEnvironmentA tmosphericPressureMi nimum UoM transportationEnviron mentAtmosphericPres sureMaximum UoM and transportationEnviron men
268. roup applicable Device TRUE initialManufacturerSter DRY_HEAT This is a code value for population with the AVP Packaged as ilisationCode attribute extendedlnitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialManufacturerSter ETO_ETHYLENE_OXIDE A gas that is commonly used to sterilize objects Packaged as ilisationCode sensitive to temperatures greater than 60 C such Sterile as plastics optics and electrics Ethylene oxide treatment is generally carried out between 30 C and 60 C with relative humidity above 30 and a gas concentration between 200 and 800 mg L for at least three hours Ethylene oxide penetrates well moving through paper cloth and some plastic films and is highly effective Device TRUE initialManufacturerSter HIGH_INTENSITY_LIGHT_ This is a code value for population with the AVP Packaged as ilisationCode OR_PULSE_LIGHT attribute extended nitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Device TRUE initialManufacturerSter HIGH This is a code value for population with the AVP Packaged as ilisationCode LEVEL_DISINFECTANT attribute extendedl nitialSterilisationPriorToUse Sterile This value will be added to the SterilisationTypeCode list in a future GDSN release Release 2 0 Ratified Oct 2015 2015 GS1 AISBL
269. rown s spreadsheet 20150126 V20 Changes to sheet based on changes made by FDA to their documentation Added phrase Must be from same Issuing Agency as Primary DI to the GUDID Data Entry Notes for the FDA Attribute Unit of Use DI Number Added phrase Must be from same Issuing Agency as Primary DI to the GUDID Data Entry Notes for the FDA Attribute DM DI Number Added phrase Must be from same Issuing Agency as Primary DI to the GUDID Data Entry Notes for the FDA Attribute Unit of Package DI Number Removed the date format tag yyyy mm dd from the name of the FDA GUDID Attributes DI Record Publish Date and Commercial Distribution End Date Updated the SPL Attribute Name for the FDA GUDID Attribute Issuing Agency in the Secondary DI section to be Issuing Agency of Secondary DI Updated the last line in the GUDID Data Entry Notes for the FDA Attribute Customer Contact Email to be If a phone number is entered and you don t have a Customer Contact email please enter xx xx xx Removed the SPL Attribute Name for the FDA GUDID Attributes Customer Contact Phone and Customer Contact Email Renamed SPL Attribute name of the FDA Support Contact Phone to Customer Contact Phone Updated the length of the FDA Attribute Premarket Submission Supplement Number to be Length CDRH 1 3 digits CBER 1 4 digits Updated the GUDID Data Entry notes for the FDA Attribute GMDN Code to be Enter all applicable GMDN Preferred
270. rton contains base package DI 101 Package DI 202 Carton contains base package DI 101 Package DI 301 contains lower level Package DI 201 Carton Add Addition of new data is allowed Conditional ly Required If Package DI is entered NA DI numbers base package and all lower levels of packaging NO Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 40 of 218 Data Element Description Data Entry Notes Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Package Text to describe the outer packaging Enter name or Add Addition of new Optional Type NA NO Private Type of the product and enables users to description of data is allowed Alphanum understand higher level packaging package configurations This field is free text Length 20 There is no implied definition or standard quantity to any package name Package Indicates the date this particular Choose date from Add Addition of new Conditional Type NA NO Public Discontin package configuration is calendar or manually data is allowed ly Num date ue Date discontinued by the labeler enter in format Required format yyyy mm dd If Length 10 Discont
271. ry Class DateTime Multiplicity Optional Occurrence Single Definition Communicates the date on which the trade item is no longer to be manufactured Code List Name N A Population Guidance below This attribute is populated from the globalTradeltemNumber record which is being used to populate the GUDID Package DI Number This date is the date when the Package DI has been discontinued or removed from the marketplace If the Primary DI has reached its lastShipDate then any Package DI attached to the Primary DI will need to have a discontinueDate populated This ensures that a Package is not in commercial distribution when the contents of the package are not in commercial distribution However a Package DI can be not in commercial distribution when the contents of the package are in commercial distribution Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be deleted Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 173 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline 6 25 Package Status FDA GUDID Description Indicates whether the package is in commercial distribution as defined under 21 CFR 807 3 b Data Entry Notes Auto populated based on Package Discontinue Date If Package DI and related elements are entered and no Package Distribution E
272. s of GS1 Moreover the agreement to grant licences provided under the GS1 IP Policy does not include IP rights and any claims of third parties who were not participants in the Work Group Accordingly GS1 recommends that any organization developing an implementation designed to be in conformance with this Specification should determine whether there are any patents that may encompass a specific implementation that the organisation is developing in compliance with the Specification and whether a licence under a patent or other intellectual property right is needed Such a determination of a need for licencing should be made in view of the details of the specific system designed by the organisation in consultation with their own patent counsel THIS DOCUMENT IS PROVIDED AS IS WITH NO WARRANTIES WHATSOEVER INCLUDING ANY WARRANTY OF MERCHANTABILITY NONINFRINGMENT FITNESS FOR PARTICULAR PURPOSE OR ANY WARRANTY OTHER WISE ARISING OUT OF THIS SPECIFICATION GS1 disclaims all liability for any damages arising from use or misuse of this Standard whether special indirect consequential or compensatory damages and including liability for infringement of any intellectual property rights relating to use of information in or reliance upon this document GS1 retains the right to make changes to this document at any time without notice GS1 makes no warranty for the use of this document and assumes no responsibility for any errors which may appear in the d
273. same Issuing Delete Deletion of ly Alphanum Number only applicable to devices Agency as Primary entered data is Required subject to Direct Marking DI allowed Length requirements under 21 CFR 801 45 Data type and field Edit Editing of entered If device min 6 length are data is allowed subject to max 23 determined by the 801 45 individual Issuing and DM defined Agency structure DI by Issuing Different Agency GS1 Numeric from structure Num with 14 Primary DI digits is checked HIBCC Alphanumeric Alphanum with 6 23 characters ICCBBA Alphanumeric with 10 or 16 characters Secondary DI Issuing Name of Secondary DI Issuing Choose a value from None NO edit add or Optional NA GS1 HIBCC NO Public Agency of agency the drop down LOV delete are allowed CCBBA Secondary NDC NHRIC DI Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 36 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Secondar Enter Secondary DI Number None NO edit add Optional Type NA Enter NO Public y DI If your product is labeled with a UDI or delete are allowed Num or Secondary DI Number and barcode from more than one Alphanum Number issuing agency for regulatory or If your marketing reasons you must Length product is choose one issuing agency system as min 6 labeled with a the Primary DI and enter the other max
274. scription where Code Group applicable Package Type Box packagingTypeCode BX Box A non specific term used to refer to a rigid three dimensional container with closed faces that completely enclose its contents and may be made out of any material Even though some boxes might be reused or become resealed they could also be disposable depending on the product hierarchy Package Type Cage packagingTypeCode CG Cage A container enclosed on at least one side by a grating of wires or bars that lets in air and light Package Type Card packagingTypeCode CM Card A flat package to which the product is hung or attached for display Package Type Clam Shell packagingTypeCode CMS Clam Shell A one piece container consisting of two halves joined by a hinge area which allows the structure to come together to close Clamshells get their name from their appearance to the shell of a clam which it resembles both in form and function Package Type Can packagingTypeCode CNG Can A metallic and generally cylindrical container of unspecified size which can be used for items of consumer and institutional sizes Package Type Crate packagingTypeCode CR Crate A non specific term usually referring to a rigid three dimensional container with semi closed faces that enclose its contents for shipment or storage Crates could have an open or closed top and may have internal divers Even though some crates might be reused or become resealed they could also
275. se wide data governance policies roles and responsibilities which outline who has the authority to create modify and approve the data GS1 strongly recommends that each Brand Owner ensure they have a robust Information MDM amp G and data quality process in place as part of their internal data preparation process Data Quality Good data quality is a key ingredient of any efficient supply chain Having the means to continuously maintain high quality data is not only vital to reducing errors and improving patient safety but also to reducing errors in the supply chain It is also fundamental to increasing efficiency reducing costs and positively impacting customer satisfaction Good quality data means that all master data is complete consistent accurate time stamped and industry standards based By improving the quality of data trading partners reduce costs improve productivity and accelerate speed to market Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 20 of 218 1 7 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline For more information on GS1 data quality best practices and recommendations refer to the Data Quality page on the GS1 website Some regulators may include specific business and data validations to ensure data quality of the information provided by the Brand Owner Please refer to the specific regulation for more information Data Management Data Ma
276. should include notification of the change to the data owner for approval 6 Inactivate and Archive As information is obsoleted and purged it should be removed from active use This may include a flag to indicate that a particular data element is inactive and is no longer used but it is not removed from the listing This is a very relevant step in UDI regulation which requires data which has been made inactive to be permanently stored in a UDI database In general master data management the data element can be archived from the internal active database The determination of which action applies usually depends on particular use case for which the data is intended such as UDI regulation 7 Purge Generally speaking outdated information should be deleted from systems where it has been stored as part of the publication process This should include the generation of a Purge List which should be provided to the internal data owners and users some cases this may include the approval of the purge by the data owner The U S FDA UDI rule includes specific requirements regarding the information lifecycle management which may supersede guidance found in this document For additional information refer to the U S FDA GUDID User s Guide Data Governance Data governance relates to an enterprise wide process which includes decision authority policy and issue escalation An enterprise wide Data Governance process should include data management
277. signed Figure 5 1 GDSN to GUDID Attribute Table legend Header FDA GUDID Code Attribute Code Group Definition The name of the FDA GUDID Data Element for which the code being described is relevant Code Value The name of the code value or entry list value as assigned in the FDA GUDID GS1 GDSN Attribute Name The name of the attribute as listed in the GS1 Global Data Dictionary GDD for use with GDSN v3 1 GS1 GDSN Code Value GS1 GDSN Code Description where applicable The code value for the specified GS1 GDSN attribute A descriptive term for the specified code value where the code value is not fully descriptive This is only populated where it is appropriate or needed Definition Text defining the code value Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 91 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Figure 5 2 GDSN to GUDID Code Mapping Table FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute Description where Code Group applicable Labeler DUNS additionalPartyl dentifi DUNS DUNS Data Universal Numbering System Itis a nine Number cationTypeCode digit numbering system which uniquely identifies an individual business The DUNS number is a nine digit number issued by Dun amp Bradstreet assigned to each business location in the D amp
278. stinct identification code may take the form of a Donation Identification Number DIN serial number lot number or a combination of these production identifiers Pls Labelers of HCT Ps regulated as medical devices should select the appropriate type of PI that appears on the label of the device Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional If no data is provided No is stored Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 177 of 218 Description Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Indicates that the product contains or consists of human cells or tissues that are intended for implantation transplantation infusion or transfer into a human recipient as defined under 21 CFR 1271 3 Data Type amp Length Type Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module AVP Content Attribute Role doesTradel temContainHumanTissue Datatype Secondary Class Boolean Multiplicity Optional Occurrence Single Definition The trade item has as a component or ingredient human tissue The amount of tissue is not limited to a certain amount any amount will cause a flag of TRUE Code List Name N A Population Guidan
279. t UoM Temperature transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage Cel Degrees storageHandlingTemp Temperature CEL Degree Celsius Celsius also historically known as centigrade is a temperature scale the freezing point of water is 0 degrees Celsius C and the boiling point 100 C at standard atmospheric pressure placing the boiling and freezing points of water exactly 100 degrees apart Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 142 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition UoM Storage K Degrees Kelvin storageHandlingTemp Temperature KEL Kelvin Kelvin a unit of absolute temperature equal to and Handling eratureMaximum 1 273 16 of the absolute temperature of the triple Units of UoM point of water One kelvin degree is equal to one Measure storageHandlingTemp Celsius degree Storage eratureMinimum Environment UoM Temperature transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling tmosphericPressureM Units of aximum UoM Measure storageEnvironmentA Storage tmosphe
280. tAtmosphericPres sureMinimum UoM Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 136 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Code Group Code Name Code Definition and Handling Units of Measure Handling Environment Temperature Celsius eratureMaximum UoM storageHandlingTemp eratureMinimum UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Relative Humidity dityMaximum UoM Units of storageHandlingHumi Measure dityMinimum UoM Handling transportationHumidi Environment tyMaximum UoM Humidity and transportationHumidi tyMinimum UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing and Handling Fahrenheit eratureMaximum point of water is 32 degrees Fahrenheit F and Units of UoM the boiling point 212 F at standard atmospheric Measure storageHandlingTemp pressure placing the boiling and freezing points of Handling eratureMinimum water exactly 180 degrees apart Environment UoM Temperature transportationMaximu mT
281. tAtmosphericPressMaximum AVP atmospheric pressure transportationEnvironmentAtmosphericPressMinimum For the GUDI D the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and others have a single or recommended value Population of all possibilities can be handled in the GDSN and the GUDID using the following chart Information Type Available Populated In Value Range of Lowest to Highest Minimum or Low Values Field Lowest Value Maximum or High Values Field Highest Value Less Than a Value Minimum or Low Values Field Leave Null provide no value Maximum or High Values Field Highest Value Greater Than a Value Minimum or Low Values Field Lowest Value Maximum or High Values Field Leave Null provide no value Single or Recommended Value Minimum or Low Values Field Single Same Value populated in both Maximum or High Values Field UEIGE Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 209 of 218 6 57 FDA GUDID Description High Value SPL Name Storage and Handling High Value Indicates storage and handling requirements that are required for the device including temperature
282. ta Type amp Length Optional Type Num or Alphanum Length min 6 max 23 defined by Issuing Agency structure Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role additionalTradel teml dentification Datatype Secondary Class AdditionalTradeltemldentification Multiplicity Mandatory If module is invoked Occurrence Single Definition Alternative means to the Global Trade Item Number to identify a trade item Code List Name N A Population Guidance The GS1 General Specifications stipulate that a Trade Item can only have one GTIN As the GTIN is the primary DI for an item using GDSN to provide data to the GUDID a GTIN can not bea Secondary DI However the item might have a Secondary DI from another issuing agency s item number standard Using the pair of GDSN attributes additionalTradel teml dentificatonTypeCode and additionalTradeltemldentificaton these other issuing agency identifiers can be provided Currently there are code values for other issuing agencies which would have an associated additionalTradeltemldentificaton provided to the GUDID If a value is populated for additionalTradeltemldentificaton through GDSN for an issuing agency using the attribute additionalTradel teml dentificatonTypeCode it will be provided to the GUDID as a secondary DI The codes available for the Secondary DI Issuing Agency
283. tactTypeCode Datatype Secondary Class Code Code List Name Multiplicity Mandatory if Module invoked Occurrence Single Definition The general category of the contact party for a trade item for example Purchasing ContactTypeCode CONSUMER_SUPPORT Module CommunicationChannel Content Attribute Role Attribute communicationChannelCode Datatype Secondary Class Code Multiplicity Mandatory if Module invoked Occurrence Single Definition Code specifying the type of communication channel for example TELEPHONE Code List Name CommunicationChannelCode TELEPHONE Module CommunicationChannel Content Attribute Attribute Role communicationChannelValue Datatype Secondary Class String Text 1 200 Characters Multiplicity Mandatory if Module invoked Occurrence Single Definition Text identifying the endpoint for the communication channel for example a telephone number or an e mail address Code List Name N A Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 175 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidance below The GDSN attribute contactType signifies which type of contact information is being provided The GDSN attributes communicationChannelCode and communicationChannelValue can repeat as a pair of attributes for
284. te Code Group Code Group UoM Volume kL Kiloliter netContent Volume K6 Kilolitre A kilolitre is one thousand 1000 litres Units of Measure Total Volume UoM Volume L Liter netContent Volume LTR Litre A litre is defined as a special name for a cubic Units of decimetre 1 L 1 dm3 103 cm3 Measure Total Volume UoM Volume mL Milliliter netContent Volume MLT Millilitre A millilitre is one thousandth of a litre 0 001 Units of Measure Total Volume UoM Volume nL Nanoliter netContent Volume NAN Nanolitre Nanolitre is the metric unit of volume equal to one Units of billionth of a litre which can be represented Measure Total numerically as 0 000000001 liter Volume UoM Volume pL Picoliter netContent Volume PLT Picolitre Picoliter is the metric unit of volume equal to a Units of trillionth one millionth of a millionth of a liter Measure Total which can be represented numerically as Volume 0 000000000001 liter just as the prefix nano denotes a billionth part UoM Volume uL Microliter netContent Volume 2X Metre Per Minute Metre Per Minute Units of Measure Total Volume UoM Weight Ib av Pound grossWeight and Mass LBR Pound The international avoirdupois pound of exactly Units of netContent 0 45359237 kilogram Measure Weight UoM Weight ston_av Ton grossWeight and Mass STN Ton US or short ton Ton US 2000 Lb or 907 Kg Units of netContent UK Measure Wei
285. te the product information may reside in the UDID but will not be visible to the public This data is not changeable Code List Name N A Population Guidance below This attribute is a temporary attribute AVP in GDSN uDIDPublishDate It will be deployed into the GDSN Schema in 2016 17 into a final solution The final solution will be relationship dependent which allows for a different yet specific value to be provided for each UDI Ds This attribute can not be changed or edited once the date has been reached For example if the date is populated as 20140920 then after 9 9 2014 this date can not be edited The Labeler will need to pay particular attention to this date On this date the device information will be published by the FDA to the public GUDID site Once published a 7 day grace period begins Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 158 of 218 6 13 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline During the grace period most attributes can be edited After the grace period ends on day 8 many of the data elements are locked and can no longer be edited If the current date is equal to or greater than the GUDID Publication Date uDIDPublishDate in GDSN then the GUDID attribute Commercial Distribution Status will be set to In Commercial Distribution automatically by the FDA Commercial Distribution End Date FDA GUDID Description Indica
286. ted in the SP Throughout document where the SPL Information is different from the GUDI D Web Guideline document the SPL information has been added in highlighted red text If either document is amended to match the other the text will be edited to match the changes The following are specific changes made Updated the GUDID Data Element field with the SPL Name for Support Contact Phone Support Contact Email Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Size Type Text Storage and Handling Type High Value Low Value Unit of Measure Updated the GUDID Definition field with SPL Definition for Labeler DUNS Number Secondary DI Number Contains DI Package Support Contact Phone Support Contact Email Device Exempt from Premarket Submission Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code Lot or Batch Number Manufacturing Date Serial Number Expiration Date Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 Device labeled as Not made with natural rubber latex MRI Safety Status Size Unit of Measure Storage and Handling Type High Value Low Value Unit of Measure Special Storage Conditions Updated the GUDID Required Field with the SPL Text for Package DI Number Contains DI Package Package Discontinue Date Support
287. tent Attribute Attribute Role tradeltemUnitDescriptorCode Code Datatype Secondary Class Multiplicity GDSN Mandatory Occurrence Single Definition Describes the hierarchical level of the trade item TradeltemUnitIndicator is mandatory Examples CASE PALLET TradeltemUnitDescriptorCode values other than BASE_UNIT_OR_EACH Code List Name Population Guidance below The GUDID Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package m Package Type m Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references a GTIN in the hierarchy above the primary DI This would be or is one of the parent s of the primary DI These parents are identified by their own GTIN and GDSN Message They are linked together through the use of the parent child relationship Population of the GUDID values for the package information will be based on any value populated in the GDSN attribute tradeltemUnitDescriptor with the exception of BASE _UNIT_OR_EACH The GTIN with a tradeltemUnitDescriptor value of BASE_UNIT_OR_EACH will always be a Primary DI for the GUDID See the examples below In GDSN the follo
288. tered Data Type amp Length Type Alphanum Length 100 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public Device Status Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 43 of 218 Data Element Human Cell Tissue or Cellular or Tissue Based Product HCT P Description Indicates that the product contains or consists of human cells or tissues that are intended for implantation transplantation infusion or transfer into a human recipient as defined under 21 CFR 1271 3 Data Entry Notes Select checkbox if DI record is fora product defined under 21 CFR 1271 3 If checked the labeler must assign and label each HCT P device with a distinct identification code per 21 CFR 1271 290 c The distinct identification code may take the form of a Donation Identification Number DIN serial number lot number or a combination of these production identifiers Pls Labelers of HCT Ps regulated as medical devices should select the appropriate type of PI that appears on the label of the device Edit Editing of entered data is allowed Rules after Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional If no data is provided No is stored Data Type amp Length Type Boolean En
289. tes the date the device is no longer held or offered for sale See 21 CFR 807 3 b for exceptions The device may or may not still be available for Data Entry Notes Choose date from calendar or manually enter date in new format yyyy mm purchase in the marketplace dd Drop down is for Webtool only Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional Data Type amp Length Type Num date format Length 10 Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Content Attribute Attribute Role lastShipDate Datatype Secondary Class DateTime Multiplicity Optional Occurrence Single Definition Indicates the latest date that the trade item can be shipped This is independent of any specific ship from location Code List Name N A Population Guidance below This date signals that a trade item will no longer be in distribution from the Labeler If the current date is equal to or greater than the GUDID Commercial Distribution End Date lastShipDate in GDSN then the GUDID attribute Commercial Distribution Status will be set to Not in Commercial Distribution automatically by the FDA Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 159 of 218 Leveraging GDSN for the FDA Global Unique Device Ident
290. th 6 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN for the GUDID temperature values Module TradeltemTemperaturelnformationModule Content Attribute Attribute Role minimumTemperature Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 207 of 218 Module TradeltemTemperaturelnformationModule Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Secondary Class TemperatureMeasurement Multiplicity Optional Occurrence Single Definition The minimum temperature that a trade item can be held below defined by the manufacturer without affecting product safety or quality Code List Name GS1 GDSN for the GUDID humidity values Module Content Attribute Role TradeltemHumiditylnformationModule Attribute minimumHumidityPercentage Datatype Secondary Class Decimal Multiplicity Optional Occurrence Single Definition The minimum humidity in percentages that the goods should be stored in Code List Name GS1 GDSN for the GUDID pressure values use of any of these attributes below will point to GUDI D pressure values Module Content AVP Attribute Role storageEnvironmentAtmosphericPressureMinimum Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The minimum pr
291. the manufacturer without affecting product safety or quality Code List Name GS1 GDSN for the GUDID humidity values Module TradeltemHumidityInformationModule Content Attribute Attribute Role minimumHumidityPercentage Datatype Secondary Class Decimal Multiplicity Optional Occurrence Single Definition The maximum humidity in percentages that the goods should be stored in Code List Name Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 210 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN for the GUDID pressure values use of any of these attributes below will point to GUDID pressure values Module AVP Content Attribute Role storageEnvironmentAtmosphericPressureMaximum Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum pressure at which the trade item can be stored and handled This uses a measurement consisting of a unit of measure and a value Code List Name Module AVP Content Attribute Role trasnportationEnvironmentAtmosphericPressMax Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not
292. the industry to help define the product Multiple variants can be established for each GTIN This is a repeatable field e g Style Colour and Fragrance Allows for the representation of the same value in different languages but not for multiple values additionalTradel tem Description Commercial Distribution uDIDPublishDate DateTime The date upon which the Trade Item can be published by the Unique Device Identifier Database UDID in their public facing systems Until this date the product information may reside in the UDID but will not be visible to the public This data is not This attribute is trading partner dependent The specific UDID GLN should be provided with the date to ensure the correct date is sent to that UDID uDIDPublishDate DI Record AVP Publish Date yyyy mm dd Commercial DeliveryP Distribution urchasingl End Date nformatio yyyy mm nModule dd Release 2 0 Ratified Oct 2015 Attribute lastShipDateTime DateTime Indicates the latest date that the trade item can be shipped This is independent of any specific ship from location 2015 GS1 AISBL lastShipDate Page 68 of 218 FDA GUDID Module Content Attribute Role Data Element Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Datatype Definition Secondary Class GDSN Notes GDSN v2 8 Attribute Name
293. the SPL Message Package DI Number Package Discontinue Date Note date format is different between the Web Portal and the SPL Message Support Contact Phone Device Exempt from Premarket Submission Supplement Number Product Code Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code MRI Safety Status Storage and Handling Type Unit of Measure Updated the GUDID Length field with SPL text for Primary DI Number Unit of Use DI Number DM DI Number Secondary DI Number Package DI Number Contains DI Package Device Code Split into two parts GMDN Preferred Term Code and a new attribute FDA Preferred Term Code Exempt from Premarket Submission FDA Premarket Submission Number Supplement Number Product Code MRI Safety Status Storage and Handling Type Unit of Measure Updated the GUDI D Values Terminology field with the SPL Text for Device Exempt from Premarket Submission Added updated and deleted codes values for the Clinical Size Type Angle Area Surface Area Outer Diameter Pore Size Pressure and Width Page 10 of 218 Release Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Date of Change Changed By Summary of Change 5 09 May 2014 Scott Brown Corrections to the document sections 3 4 5 to correct the following Corrected the case for the clinical size text code list to be upper case Corrected t
294. the intended use together as defined under 21 CFR 3 2 e At least one of the products in the combination product must be a device in this case if the product is a constituent part of a combination product Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Optional Data Type amp Length Type Boolean Entry List of Values LOV NA New DI Trigger YES Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Module AVP Content Attribute Role groupedProduct Datatype Secondary Class Code Multiplicity Optional Occurrence Single Definition Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Code List Name GroupedProductCode COMBINATION or KIT_AND_COMBI NATION Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 179 of 218 6 31 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Population Guidance below This attribute has a temporary attribute AVP in GDSN groupedProduct It will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attribute groupedProduct is a code list attribute It is used to specify if an item is a kit or a combination product A value populated for the GDSN attribute groupedProduct of COMBINATION or KIT
295. the product and may be the same for several GTINs where they are variations of each other For example a coffee mug with 3 GTINs one each for the brown mug the white mug and the black mug might all be the supplier assigned number of AB123 Use of this value is recommended in the absence of a Model Number or Manufacturer s Part Number Secondary DI GS1 additionalTradel teml d Not needed as there can only be one GTIN for Number entificationTypeCode an item and therefore can not be a secondary GTIN Size Type Angle clinicalSizeType ANGLE Temporary GDSN value pending future GDSN deployment Size Type Area Surface Area clinicalSizeType AREA_SURFACE_AREA Temporary GDSN value pending future GDSN deployment Size Type Circumference clinicalSizeType CIRCUMFERENCE Temporary GDSN value pending future GDSN deployment Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 95 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Description where Code Attribute Code Group applicable Size Type Depth clinicalSizeType DEPTH Temporary GDSN value pending future GDSN deployment Size Type Device Size Text clinicalSizeType DEVICE_SIZE_TEXT_SPECI Temporary GDSN value pending future GDSN specify FY deployment Size Type Catheter Gauge clinica
296. this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details Prescription Use Rx FDA GUDID Description Indicates that the device requires a prescription to use Data Entry Notes Select checkbox if appropriate Can select both Rx and OTC for one DI record Webtool Edit Rules After Grace Period Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Required Optional If no data is provided No is stored Data Type amp Length Type Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 197 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline GS1 GDSN Module SalesInformationModule Content Attribute Attribute Role consumerSalesConditionCode Datatype Secondary Class Code Multiplicity Optional Occurrence Multiple Definition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required Code List Name ConsumerSalesConditionTypeCode PRESCRIPTION REQUIRED Population Guidance below This GDSN attribute is a code list of values signifying how the item is presented for sale to a consumer If a value of PRESCRIPTI
297. tialSterilisationPriorToUseChlorineDioxide isl nitialSterilisationPriorToUseDryHeat isl nitalStrilistonPriorHighl ntensityOrPulseLight isl nitialSterilisationPriorToUseMicrowaveRadiation isl nitialSterilisationPriorToUseSoundWaves isl nitialSterilisationPriorHighLevelDisinfectant isl nitialSterilisationPriorToUseLiquidChemical isl nitialSterilisationPriorToUseNitrogenDioxide isl nitalStrilistonPrirSupercriticalCarbonDioxide Release 1 2 Issue 1 22 August 2014 John Ryu eBallot Approved and closed IP review Publication Update Added tables into section 6 Guidance on Populating Values for ease of readability Removed strikethrough text example tmm ddyyyy yyyy mm dd Release 1 2 Issue 1 6 Nov 2014 David Buckley Ratified version Release 1 3 Draft 1 9 January 2015 Pete Alvarez Clarification regarding the use of a GDSN Data Pool to register data in the U S FDA GUDI D Updated Section 1 Introduction 2 GDSN Data Flow 7 Reference Document Title change From GDSN for the FDA Global Unique Device Identifier Database GUDID TO Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 12 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDI D Implementation Guideline Release 1 3 Draft 2 28 January 2015 John Ryu based on Scott B
298. tiplicity Optional Occurrence Single Definition The minimum pressure at which the trade item can be stored and handled This uses a measurement consisting of a unit of measure and a value Code List Name Content Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 205 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module AVP Attribute Role trasnportationEnvironmentAtmosphericPressMax Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected Code List Name Module AVP Content Attribute Role transportationEnvironmentAtmosphericPressMin Datatype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected Code List Name Population Guidance below This GUDID attribute will have several different mappings from GDSN based on the needed piece of information To provide Temperature information to the GUDID the GDSN attribute teperatureQualifierCode is in a repeatable group of attributes which incl
299. to normal GDSN recipients for their use following their existing processes 6 39 Definition FDA GUDID Description Description associated with the GMDN Preferred Term Code FDA PT Code Data Entry Notes System populated based on GMDN Preferred Term Code FDA PT Code Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 189 of 218 Description Edit Rules After Grace Period Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Description associated with the GMDN Preferred Term Code FDA PT Code NA data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length N A Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role N A Datatype Secondary Class Auto Populated by FDA for the GUDID based on the GMDN Code Multiplicity N A Occurrence N A Definition N A Code List Name N A Attribute Name N A Definition N A Data Type N A GDSN Required 1 1 Required Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the GMDN Preferred Term Code submitted 6 40 For Single Use FDA GUDI D Description Indicates that the device is intended for one use or on a sin
300. tribute list The choice of attributes in this guidance is related to the GUDID to GDSN Mapping provided in section 4 The guidance is ordered accordingly in line with the order as presented from the FDA documentation 6 1 Issuing Agency FDA GUDID C10 BUD DY elgle areya GUDID Data Entry Notes Organization accredited by FDA to operate a system for the issuance of UDIs Choose a value from the drop down LOV Webtool Edit Rules After Grace Period GUDID Required in Database None NO edit add or delete are allowed Required GUDID Data Type amp Length NA GUDID Entry List of Values LOV GS1 HIBCC ICCBBA New DI Trigger YES Public Private Status PUBLIC GS1 GDSN Module N A Content N A Attribute Role N A LOGICAL POPUALTION Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below LOGICAL POPULATION On the outbound GUDID Message by the Data Pool Will use the value GS1 in all GDSN instances By using GDSN the GTIN of the lowest level of the hierarchy will become the Primary DI By using a GTIN as the Primary DI this will require the issuing agency to be GS1 Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked Releas
301. try List of Values LOV NA New DI Trigger NO Public Private Status Public Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Kit Indicates that the device is a convenience combination in vitro diagnostic IVD or medical procedure kit Kits are a collection of products including medical devices that are packaged together to achieve a common intended use and is being distributed as a medical device Select checkbox if DI record is for a kit Do not check if the device is a constituent part of a kit None NO edit add or delete are allowed Optional If no data is provided No is stored Type Boolean NA YES Public Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 44 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Combinati Indicates that the product is Select checkbox if DI None NO edit add or Optional Type NA YES Public on Product comprised of two or more regulated record is fora delete are allowed Boolean products that are physically combination product If n
302. ublic Record published and available via Public calendar or manually delete are allowed Num date A Search enter date in new format Publish format yyyy mm Date dd Length 10 This date determines the Grace Period the 7 calendar days start the day after the DI Record Publish Date This date should be set in the future to allow time to ensure accurate data entry We recommend you set this date in the future but 7 days prior to any compliance deadline Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 33 of 218 Data Element Description Data Entry Notes Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Edit Editing of entered data is allowed Rules after Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Distribution End Date is entered the status is In Commercial Distribution depends on another data element Commerci Indicates the date the device is no Choose date from Add Addition of new Optional Type NA NO Public al longer held or offered for sale See calendar or manually data is allowed Num date Distributio 21 CFR 807 3 b for exceptions The enter date in new Delete Deletion of format n End device may or may not still be format yyyy mm entered data is Date available for pu
303. ude minimumTemperature maximumTemperature and temperatureMeasurementUnitCode Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE_HANDLING the GUDID values for Storage Environment Temperature will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Temperature will be provided To provide Humidity information to the GUDID the GDSN attribute humidityQualifierCode is in a repeatable group of attributes which include minimumHumidityPercentage and maximumHumidityPercentage Combined this group will provide the full complement of information for the specified qualifier For the GDSN qualifier value of STORAGE HANDLING the GUDID values for Storage Environment Humidity will be provided For the GDSN qualifier value of TRANSPORTATION the GUDID values for Handling Environment Humidity will be provided The GDSN attributes correlating to the GUDID attributes for atmospheric pressure are temporary attributes AVP in GDSN They will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attributes are in two pairs One pair is for the GUDID storage pressure attributes storageEnvironmentAtmosphericPressureMinimum and storageEnvironmentAtmosphericPressureMaximum The other pair is for the GUDID transportation pressure transportationEnvironmentAtmosphericPressMin and transportatio
304. ue in the GDSN attribute additionalTradeltemClassificationCode Only the GMDN Preferred Term will be populated in the GUDID This set of attributes will also be used to populate several pieces of information FDA Product Code FDA Premarket Submission Number FDA Preferred Term Code and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 188 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline The SPL Guidance states As stipulated in the Final UDI Rule 78 FR 58786 FDA has developed a new GUDID module Find FDA Preferred Term PT Codes that will enable users to select a FDA PT Code to be used in their GUDID submission until a GMDN PT code can be obtained from the GMDN Agency The Find FDA PT Code module is enabled in GUDID v1 1 and can be accessed via the GUDID Web Interface by Coordinator and Labeler Data Entry LDE Users of GUDID Note these FDA PT Codes only apply to GUDID cannot be used in place of GMDN PT Codes for any other system The population of a GMDN Code via GDSN has been available for some time While the FDA will not make the code available to the Public in the GUDID GDSN will pass the code along to normal GDSN recipients for their use following their existing processes The FDA will use the code provided to access the GMDN Preferred Term from the current GMDN
305. uggestions before e Area adding values to the Angle Size Type LOV More than one Size Value per Type and more than one Size Type may be added to each DI record Size Value Numeric value for the clinically Enter numeric value Add Addition of new Conditional Type NA NO Public relevant size measurement of the for size data is allowed ly Num medical device Decimals are Required accepted fractions Length 40 are not accepted Required Each Size Value if device is should be entered available in separately GUDID is more than not accepting Size one size Value as a range at this time Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 56 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Size Unit of Measure The unit of measure associated with each clinically relevant size SPL Text The unit of measure associated with each clinically relevant size The unit of measure must conform to UCUM standards Choose a value from the drop down Add Addition of new data is allowed Conditional ly Required Required if device is available in more than one size NA For length Centimeter Decimeter Feet Femtometer Inch Kilometer Meter Micrometer Millimeter Nanometer Picometer Yard For area Square centimeter Square foot Square inch Squa
306. w or High but can enter both Low Value and High Value if needed When Storage and Handling value is a range this is the lower end of that range When Storage and Handling value is less than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling High Value Updated the GUDID Data Entry notes for the FDA Attribute High Value to be Enter a number for High Value Must enter at least one value Low or High but can enter both Low Value and High Value if needed When Storage and Handling value is a range this is the higher end of that range When Storage and Handling value is greater than a value enter the number here When Storage and Handling value is exactly a value enter the value here and in Storage and Handling Low Value Updated the list of values for the FDA Attribute Storage and Handling Unit of Measure Added Millibar for Storage and Handling Pressure Removed GDSN Attribute Tradel temDescription text from the attributes for concatenation into the FDA GUDID Attribute Device Description Added GDSN notes for the GDSN attribute initialSterilisationPriorToUse Release 1 3 1 Draft 1 4 March 2015 John Ryu WR 15 043 Errata Change Deleted two sentences below 6 50 What MRI safety information does the labeling contain Population Guidance below This GDSN attribute is a code list of values signifying if the device is safe for use in an MR
307. wing is provided Hierarchy Number 1 globalTradeitemNum_ tradeltemUnitDescrip ChildTradeltem globa quantityofNextL ber tor ITradeltemNumber owerLevelTrade Item 2061414111111c CASE 1061414111111c 5 5 cartons ina case 1061414111111c PACK_OR_INNER_PA_ 0061414111111c 4 4 boxes ina CK carton 0061414111111c BASE_UNIT_OR_EAC N A N A 1 Box of Gloves H Hierarchy Number 2 globalTradeitemNum_ tradeltemUnitDescrip ChildTradeltem globa quantityofNextL ber tor ITradeltemNumber owerLevelTrade Item 4061414111111c CASE 3061414111111c 2 2 cartons ina case Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 167 of 218 globalTradeitemNum ber tradeltemUnitDescrip tor ChildTradeltem globa ITradeltemNumber quantityofNextL owerLevelTrade Item Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Notes 3061414111111c PACK_OR_INNER_PA 0061414111111c 10 10 boxes ina CK carton 0061414111111c BASE_UNIT_OR_EAC N A N A 1 Box of Gloves H This is converted to the following for population in the GUDI D On the GUDID record for Primary DI 0061414111111c Package DI Number Quantity per package Contains DI Package Notes 1061414111111c 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111c 5 3061414111111c Indicates there are 5 packs in the case 3061414111111c 10 0061414111111c I
308. ximum UoM storageHandlingTemp eratureMinimum UoM transportationMaximu mTemperature UoM and transportationMinimu mTemperature UoM UoM Storage kPa KiloPascal storageEnvironmentA Pressure KPA Kilopascal A thousand pascals 10 to the 3rd power and Handling tmosphericPressureM Units of aximum UoM Measure storageEnvironmentA Storage tmosphericPressureMi Environment nimum UoM Atmospheric transportationEnviron Pressure mentAtmosphericPres sureMaximum UoM and transportationEnviron mentAtmosphericPres sureMinimum UoM UoM Storage Percent Percent storageHandlingHumi Proportion P1 Percent A unit of proportion equal to 0 01 and Handling Relative Humidity dityMaximum UoM Units of storageHandlingHumi Measure dityMinimum UoM Storage transportationHumidi Environment tyMaximum UoM Atmospheric and Pressure transportationHumidi tyMinimum UoM UoM Storage degf Degrees storageHandlingTemp Temperature FAH Degree Fahrenheit The Fahrenheit temperature scale the freezing point of water is 32 degrees Fahrenheit F and the boiling point 212 F at standard atmospheric pressure placing the boiling and freezing points of water exactly 180 degrees apart Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 140 of 218 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute Leveraging GDSN for the FDA Global Unique Device Identifier Database
309. y pagination was also changed to allow for each different attribute to start a new page Updated Section 4 pages 59 74 various changes such as updating the GUDID attribute name to match previous sections equivalent GDSN attributes GDSN definitions and GDSN Notes have been made all changes are in red text with yellow highlighting Updated Section 5 pages 75 112 various changes such as updating the GUDID attribute name to match previous sections GUDID code values and equivalent GDSN Code Values have been made all changes are in red text with yellow highlighting There are several code values which have notes as to change request activity with GSMP when this work completes the document will be updated Updated Section 5 pages 113 161 the Unit of Measure UoM section of the code value table was completely redone specific additions and mapping have been highlighted in red text with yellow highlighting The table reflects several new columns in use by the GDA GUDID Guidance documents and similar columns in use by GDSN Updated Section 6 pages 162 260 listing of attributes with various changes Primarily changing the content from the FDA GUDID Guidance documents such as values for the GUDID of Attribute Name Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length and Entry List of Values LOV values for the GDSN of New Attributes and Guidance There are also various formatting
310. y or may not be the Manufactured At location The Manufactured At location is the actual facility or facilities where the device is produced or assembled A device can have more than one Manufactured At location but should only have one Manufactured By entity 6 6 Company Name FDA GUDID Description Company name associated with the labeler DUNS Number entered in the DI Record Data Entry Notes Auto populated based on the Labeler DUNS Number The labeler company name submitted to the GUDID should match the company name on the device label Edit Rules After Grace Period N A data element is not able to be changed directly most are auto populated fields whose information depends on another data element Required Auto Populated Data Type amp Length N A Entry List of Values LOV N A New DI Trigger N A Public Private Status Public GS1 GDSN Module N A Content N A Attribute Role N A Datatype Secondary Class N A Multiplicity N A Occurrence N A Definition N A Code List Name N A Population Guidance below The FDA will populate this information into the GUDID based on information from D amp B based on the Labeler DUNS provided If the information is not correct D amp B should be contacted to facilitate correcting the data Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 152 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier D
311. ype Secondary Class Measurement Multiplicity Optional Occurrence Single Definition The value to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list Release 2 0 Ratified Oct 2015 2015 GS1 AISBL Page 202 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline Module AVP Code List Name UN Recommendation 20 Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeType It will be deployed into the GDSN Schema in 2016 17 into a final solution All of the clinical attributes can be repeated as a group when this value changes In the temporary solution the attribute names end in the numbers 1 2 3 and 4 All of the attributes ending in the same number are in a group together and relate to each other This numbering will be removed in the final GDSN solution This GUDID attribute is a code list attribute specifying the clinical size unit of measure for the device s clinical size value This attribute is a numeric value and an associated Unit of Measure UoM qualifier The UoM is a code from the UN Recommendation 20 Code List The Data Pools will convert the UN Rec 20 code to the applicable code for the GUDID if needed For the GUDID the data poo
312. ypeCode BBG Bag in Box Bag In Box or BIB is a type of container for the storage and transportation of liquids It consists of a strong bladder usually made of aluminium PET film or other plastics seated inside a corrugated fibreboard box The box and internal bag can be fused together In most cases there is nozzle or valve fixed to the bag The nozzle can be connected easily to a dispensing installation or the valve allows for convenient dispensing Package Type Bag packagingTypeCode BG Bag A preformed flexible container generally enclosed on all but one side which forms an opening that may or may not be sealed after filling Package Type Bucket packagingTypeCode BJ Bucket A container usually cylindrical can be equipped with a lid and a handle e g a pail made of metal plastic or other appropriate material Package Type Basket Release 2 0 Ratified Oct 2015 packagingTypeCode BK Basket 2015 GS1 AISBL A semi rigid container usually open at the top traditionally used for gathering shipping and marketing agricultural products Page 109 of 218 Leveraging GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guideline FDA GUDID Code Value GS1 GDSN Attribute GS1 GDSN Code Value GS1 GDSN Code Definition Code Attribute Description where Code Group applicable Package Type Bottle packagingTypeCode BO Bottle A conta

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