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GDSN for the FDA Global Unique Device Identifier Database

1. netContent X_PPC Pixel per centimetre A unit of count defining the number of pixels per linear centimetre as a measurement of the resolution of devices in various contexts typically computer displays image scanners or digital camera image sensors Apr 2014 Version 1 All contents GS1 Page 155 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition A unit of count defining the number of pixels per linear inch PPI as a measurement of the resolution of devices in netContent X_PPI Pixel per inch ANER various contexts typically computer displays image scanners or digital camera image sensors Application e g netContent Z51 in hair colorant 6 applications Apr 2014 Version 1 All contents GS1 Page 156 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 attribute list The choice of attributes in this guidance is related to the GUDID to GDSN Mapping provided in section 4 The guidance is ordered according in line with the order as presented from the FDA documentation 1 Issuing Agency FDA GU
2. Data Element The name of the element being requested Description Text defining the element Data Entry Notes 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 Once published on the FDA GUDID public facing website ofor 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 ired Required 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 periods signifies multiple occurrences repeatability and a number after 2 periods signifies single occurrence non repeatability Data Type amp Length The type of value for the element Boolean Text Code List etc including how many characters are available for population EOV Fist ofxalues 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 signify
3. Clinically Relevant Size May 2014 Version 1 1 All contents GS1 Page 45 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID pata Public WATE aoe Data Entry Aa Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger E Size Type Dimension type O NO Public for the clinically relevant LOV measurement of uE the medical Size Value Numeric value Add Addition of Conditionally NO Public for the clinically Required relevant size measurement of the medical NA accepting Size May 2014 Version 1 1 All contents GS1 Page 46 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Size Unit of The unit of Choose a value Measure measure from the drop associated with down each Clinically relevant size NO Public TT May 2014 Version 1 1 All contents GS1 Page 47 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID patos Public a Data Type amp Entry List of New DI d r i 9 Data Element Description Required Length Values LOV Trigger Private Status Liter Hertz Size Type Text onda NO Public SPL Name NA Storage and Handling Storage and Indicates
4. GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code MIX Mixed Container Types Mixed Container Types More than one type of container is included in a shipment shipment could consist of 3 pieces that include 1 box 1 crate and 1 basket GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code ML2 MILVAN MILVAN A military owned demountable container that conforms to US and international standards and operates in a centrally controlled fleet for movement of military cargo GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code MPE Multipack Multipack GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code MRP Multi Roll Pack Multi Roll Pack GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA
5. Apr 2014 Version 1 All contents GS1 Page 226 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 46 Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Webtool Data Type amp Length Entry List of Values LOV New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name does TradeltemContainLatex Definition An indication that a trade item is made from or contains latex which refers generically to a stable dispersion emulsion of polymer microparticles in an aqueous medium Data Type Non Binary Logic GDSN Reauired OPTIONAL 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 for 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 the regulation which basically sta
6. netContent Count SH Sheet netContent Count SPS Sample Per Second netContent Count ST Set A unit of count defining the number of sets set a number of objects grouped together Apr 2014 Version 1 All contents GS1 Page 136 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute netContent GDSN for the FDA Global Unique Device Identifier Database GUDID CioW MC Bs Code Count Code Group Value SX Description Shipment Definition A unit of count defining the number of shipments shipment an amount of goods shipped or transported netContent Count U2 Tablet A unit of count defining the number of tablets tablet a small flat or compressed solid object netContent Count UN Unit netContent Count UZ Fifty Count netContent Count V2 Pouch A count of attenuation steps or netContent Count X_CHD Centisimal Hahnemannian Dilution CH dilution levels representing the homeopathic potency of a substance using the Hahnemannian CH method of attenuation commonly denoted as CH1 CH2 CH3 etc Each centesimal attenuation step represents one part source material combined with 99 parts dilution medium commonly denoted as C1 C2 C3 etc netContent Count X_KVN Korsakovian K A count of at
7. Code List OPTIONAL Final Deployment Attribute Name tradeltemDateOnPackagingTypeCode coming in Major Release in 2016 Definition Indicates the type of date marked on the packaging for example Best Before Date Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a current attribute in GDSN packagingMarkedExpirationDateType It will be changed in the GDSN Major Release in 2016 into the attribute tradeltemDateOnPackagingT ypeCode This GUDID attribute is a Boolean clarifying how the item is controlled It 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 BEST_BEFORE_DATE or EXPIRY_DATE for the current GDSN attribute packagingMarkedExpirationDateType or of BEST_BEFORE_DATE or EXPIRATION_DATE for the attribute tradeltemDateOnPackagingTypeCode signifies that the item has as one of its controls an expiration date These values signifies that the expiration date will be printed on the packaging and in the UDI Apr 2014 Version 1 All contents GS1 Page 224 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID iN 1 1 Apr 2014 Version 1 All contents GS1 Page 225 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID
8. GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CAR Carrier Carrier Apr 2014 Version 1 All contents GS1 Page 79 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CBC Containers of Bulk Cargo Containers of Bulk Cargo Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CBY Carboy Carboy Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CCS C
9. 750 MLT 20 count pack of diapers net content 20 ea In case of multi pack indicates the net content of the total trade item For fixed value trade items use the value claimed on the package to avoid variable fill rate issue that arises with some trade item which are sold by volume or weight and whose actual content may vary slightly from batch to batch In case of variable quantity trade items indicates the average quantity Numeric Code List A Z The net content attribute is a measurement attribute which is a number and a corresponding qualifier representing the unit of measure UoM The unit of measure code values are from the United Nations Recommendation 20 Code List UN Rec 20 For GDSN net content is required when the attribute isTradeltemAConsumerUnit is populated with a value of TRUE This attribute refers to if an item is the unit of end consumption 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 Apr 2014 Version 1 All contents GS1 Page 159 of 256 1 GDSN for the FDA Global Unique Device Identifier Database 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 not be changed Many of the data elements are locked and can no longer be edited Apr 2014 Version 1 All contents GS1
10. Candela per by a light source in a particular netContent Fumine cence ee Square Meter direction weighted by the luminosity function in square meters This is also known as nit in some markets netContent Luminescence B60 Lumens par Square Meter Lux is the SI unit of illuminance and luminous netContent Luminescence LUX Lux emittance measuring luminous flux per unit area grossWeight and netContent Mass 26 Actual Ton A unit of mass defining the grossWeight and netContent Mass 58 Net kilogram total number of kilograms after deductions grossWeight and netContent Mass AF Centigram The troy ounce is a unit of imperial measure In the t day it is most Troy ounce or presen grossWeight and netContent Mass APZ apothecary a an z S the EE weight an therefore the price of precious metals One troy ounce equals 480 grains or 31 1035 grams grossWeight and netContent Mass C18 Millimole Pst MOUS Gre iroveaneii of a mole Apr 2014 Version 1 All contents GS1 Page 141 of 256 FDA GUDID Code Code Value Attribute Code Group GS1 GDSN Attribute grossWeight and netContent Mass GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group C34 Description Mole Definition The mole symbol mol is the SI base unit of amount of substance one of a few units used to measure this physical quantity A mole will possess mass exactly equal to the substanc
11. GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Currently no GDSN or UN Recommendation 20 Value for FDA GUDID UoM A Question is posed to the FDA to clarify which volume trey refer UoM Pressure Units ug TotalVolume ee ae of Measure Pressure Microgram per Total clinicalSizeValue PENDING N Volume not matter Ul Recommendation 20 has the following to be used anda GDSN Change request would be entered to support GQ H29 J33 J34 J35 MC 2 The Fahrenheit temperature VETOES T ae aa ae scale the freezing point of H 7 T water is 32 degrees andling Units of storageHandlingTemperatureMinimum Fahrenheit F and the boilin Measure Handling degf Degrees UoM T t FAH Degree int 212 F at standard 9 Environment Fahrenheit transportationMaximumTemperature ampere Fahrenheit pon neii et stancen Atmospheric UoM and cimesanone pes e Pressure transportationMinimumTemperature Pa ne boiling and UoM reezing points of water exactly 180 degrees apart Celsius also historically storageHandlingTemperatureMaximu known as centigrade is a UoM Storage and m UoM temperature scale the Handling Units of storageHandlingTemperatureMinimum freezing point of water is 0 Measure Handling UoM A degrees Celsius C and the Environment Salap egestas transportationMaximum
12. Initial Manufacture ETO_ETHYLENE_OXID A gas that is commonly usedto 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 Sterilization Method Radiation Sterilization Method Dry Heat Apr 2014 Version 1 Initial Manufacture Sterilization Initial Sterilization Prior to Use GAMMA_RADIATION All contents GS1 Gamma rays are very penetrating and are commonly used for sterilization 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 Page 105 of 256 FDA GUDID Code Attribute Code Group Code Value Sterilization Method High Intensity Light or Pulse Light Sterilization Method Microwave Radiation Sterilization Method Sound Waves Sterilization Method Hydrogen Peroxide GS1 GDSN Attribute Initial Manufacture Sterilization Initial Sterilization Prior to Use GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value HYDROGEN_PEROXID E Code Description where applicable Definition Another chemical sterilizing agent It is relatively non toxic once diluted to low concentrations although a dangerous oxidizer at high concentrat
13. Public globalTradeltemNumber A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Identifier 14 digits MANDATORY 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 GTIN will always be the Primary DI All other issuing agency identification will be published as secondary 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 Apr 2014 Version 1 All contents GS1 Page 158 of 256 3 Device Count FDA GUDID GS1 Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID lt ES Public netContent amp UoM The amount of the trade item contained by a package usually as claimed on the label For example Water 750ml net content
14. Attribute Code Code Value GS1 GDSN Attribute a Renee rae Description Definition Group p Currently no GDSN Value for FDA GUDID i UoM UN i pa Pi a Recommendation nm Nanometer clinicalSizeValue C45 20 has this as Lumen Inner code C45 A DANEEN Change Request has been submitted to correct Currently no GDSN Value for FDA GUDID i UoM UN l gt pei Recommendation pm Picometer clinicalSizeValue C52 20 has this as Lumen Inner code C52 A Memeler Change Request has been submitted to correct UoM Length Size 7 7 Ez A s A micrometre is one millionth Units of Measure z clinicalSizeValue height width depth Lumen Inner um Micrometer and netContent Dimension 4H Micrometre ofa st erate termed Diameter i UoM Length Size TE RAET E P The international foot is Units of Measure ft_i Feet PaE ete r depth Dimension FOT Foot defined to be equal to 0 3048 Outer Diameter meters UoM Length Size Pe F Sree eee An international inch is Units of Measure in_i Inch e e G cegin Dimension INH Inches defined to be equal to 25 4 Outer Diameter millimeters UoM Length Size TE aa x clinicalSizeValue height width depth A yard is It is equal to 3 feet or Units of Measure yd_i Yard Dimension YRD Yard h Outer Diameter and netContent 36 inches or 0 9144 meter UoM Length Size ee p gt 7 clinicalSizeValue height width depth 3 A centimetre is equal to one Units of Measure cm
15. Code GMDN submitted Publishing the description field with the classification code name or description will provide additional value to supply chain partners receiving the message 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 Apr 2014 Version 1 All contents GS1 Page 218 of 256 39 Definition FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below Code GDSN for the FDA Global Unique Device Identifier Database GUDID Description associated with the GMDN Preferred Term Cod System populated based on GMDN Preferred Term Code FDA PT Code Auto Populated NA NA NO Public N A N A N A 1 1 Required submitted The FDA will automatically See the GUDID with a value for this attribute based on the Apr 2014 Version 1 All contents GS1 Page 219 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 40 For Single Use FDA GUDID Description Indicates that the device is intended for one use or ona single patient during a single procedure Data Entry Notes Choose Yes No fr
16. Edit Rules After Grace Period Required Data Type amp Length Enter the Version or Model Required Type Alphanum a Entry List of Values LOV New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below The GUDID is asking for a Model Number for the device This can be accomplished by the population of the code value MODEL_NUMBER in the GDSN attribute additionalPartyldentification type The actual Model Number can then be populated in the GUDID using the associated additionalPartyldentification value s Apr 2014 Version 1 All contents GS1 Page 167 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID The code value of MODEL_NUMBER is defined as Definition for GDSN Major Release 3 x in 2016 The additional Trade Item Identification value populated is an identification number which defines the configuration of the product in addition to the Item number
17. GS1 Page 106 of 256 FDA GUDID Code Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID CRIEI DRINKO 5 Code Description Count Code Group 070o CAVE IUT GS1 GDSN Attribute VAG where Definition applicable m Storage and Handling Type Storage Storage and Handling StorageHandlingHumidit Environment GDSN Attributes yMaximum OR Humidity storageHandlingHumidit yMinimum Storage and Handling Type Storage Storage and Handling StorageHandlingTemper Environment GDSN Attributes atureMaximum OR Temperature storageHandling Temper atureMinimum Storage and Handling Type Handling Storage and Handling TransportationEnvironm Environment GDSN Attributes entAtmosphericPressure Atmospheric Maximum OR Pressure transportationEnvironme ntAtmosphericPressure Minimum Storage and Handling Type Handling Storage and Handling TransportationMaximum Environment GDSN Attributes HumidityMaximum OR Humidity transportationMaximum HumidityMinimum Storage and Handling Type Handling Storage and Handling TransportationMaximum Environment GDSN Attributes Temperature OR Temperature transportationMinimumT emperature Support Customer Contact Email Use to provide the Communications Channel EMAIL N A Contact Email for GUDID Support Customer Contact Email Use to provide the Communications Channel TELEPHONE N A Contact Phone for GUDID FDA GUDID Attribute Device netContent Count 1N Coun
18. GS1 Page 214 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This attribute has a temporary attribute AVP in GDSN fDAMedicalDeviceListingNumber It will be deployed into the GDSN Schema in 2016 17 into a final solution The GUDID is asking for the FPD Medical Device Listing number assigned to the device This repeatable set of attributes will allow for the population of a FDA Medical Device Listing Number for the device This can be accomplished by the population of the code value FDA_MEDICAL_DEVICE_LISTING in the GDSN attribute additionalPartyldentification type The actual FDA Medical Device Listing can then populated in the GUDID using the associated additionalPartyldentification value s 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 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 can not be edited or deleted Apr 2014 Version 1 All contents GS1 Page 215 of 256 1 GDSN for
19. UoM Degree x transportationMaximumTemperature Tempar FA Fahrenheit PH crea ate UoM and A iff transportationMinimumTemperature lice ac uon exactly 180 degrees apart Apr 2014 Version 1 All contents GS1 Page 128 of 256 1 BY WC10 DIDE cS Attribute Code Group Code Value GS1 GDSN Attribute storageHandlingTemperatureMaximu GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Code Group Description Definition Celsius also historically known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM degrees Celsius C and the transportationMaximumTemperature TempaeiNe CEL Degree Calste boiling point 100 C at UoM and standard atmospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingT emperatureMinimum temperature equal to 1 273 16 UoM of the absolute temperature of transportationMaximumTemperature TEPENE KEL Kaikin the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum A unit of rti It UoM transportationHumidityMaximum Proportion P1
20. 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 printability 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 cod
21. ela Fahrenheit poe Ei sieneen UOM and z i iai p a a D etc freezing points of water exactly 180 degrees apart Apr 2014 Version 1 All contents GS1 Page 123 of 256 1 BY WC10 DIDE cS Attribute Code Group Code Value GS1 GDSN Attribute storageHandlingTemperatureMaximu GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Code Group Description Definition Celsius also historically storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum UoM transportationHumidityMaximum UoM and transportationHumidityMinimum UoM Proportion P1 Percent known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM degrees Celsius C and the transportationMaximumTemperature TempaeiNe CEL Degjee Calste boiling point 100 C at UoM and standard atmospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingT emperatureMinimum temperature equal to 1 273 16 UoM of the absolute temperature of transportationMaximumTemperature TEPENE KEL Kaikin the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM
22. 55 Size Type Text SPL Name Size Text FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN ce 55 5 Temporary population until final GDSN deployment clinicalSizeText Definition Data Type GDSN Required Final Deployment Attribute Name Definition Data Type GDSN Required Population Guidance below When the clinicalSizeType is coded as other 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 Text 1 200 characters OPTIONAL clinicalSizeText When the clinicalSizeType is coded as other 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 Text 1 200 characters OPTIONAL 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 clinicalSizeT ype This is free text field and should only be used if the clinical size can not 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
23. A unit of count defining the number of dots per linear inch as a measure of the resolution or sharpness of a graphic image netContent Count E55 Use A unit of count defining the number of times an object is used netContent Count EA Each A unit of count defining the number of items regarded as separate units netContent Count EV Envelope netContent Count FJ Sizing Factor Commonly used to specify an order sizing factor related to a trade item to allow standard condition brackets for a variety of items netContent Count GBQ Gigabecquerel A unit of activity equal to 109 becquerels netContent Count GRO Gross A unit of count defining the number of units in multiples of 144 12 x 12 netContent Count H87 Piece A unit of count defining the number of pieces piece a single item article or exemplar Apr 2014 Version 1 All contents GS1 Page 134 of 256 FDA GUDID Code Attribute Code Code Value Group GDSN for the FDA Global Unique Device Identifier Database GUDID CRIED Code GS1 GDSN Attribute Description Definition Code Group Value A unit of count defining the netContent Count HC Hundred count number of units counted in multiples of 100 A unit of count defining the netContent Count HD Half dozen number of units in mul
24. Apr 2014 Version 1 All contents GS1 Page 207 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 33 Supplement FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN ce 55 5 Apr 2014 Version 1 All contents GS1 Page 208 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID packaging changes in the performance or design specifications circuits components Definition N A Data Type N A GDSN Required N A Population Guidance 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 additionalClassificationAgencyName 58 additionalClassificationCategoryCode P369258 001 additionalClassificationAgencyName 58 Apr 2014 Version 1 All contents GS1 Page 209 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Once published a 7 day grace period begins During the
25. Code Description where applicable Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SHT Sheet Sheet A thin layer of material usually used as a pad for extra protection by isolating separating tiers or layers of parts within the package Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SKD Skid Skid Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SKE Skid elevating or lift truck Skid elevating or lift truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SLP Slip Sheet Slip Sheet Shipping containers utilizing slip sheets which are cardboard platforms used to hold product for storage or transportation Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should
26. Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 doesTradeltemContainLatex Non Binary Code List An indication that a trade item is made from or contains latex which refers generically to a stable dispersion emulsion of polymer microparticles in an aqueous medium This definition is currently listed on the Global Data Dictionary but will be changed in a future GDSN release to the definition and wording at this link Please use this new wording when populating the attribute Device labeled as Not made with natural rubber latex packageMarksFreeFrom Code List Indication of the food ingredients that the package is marked free from Use value of FREE_FROM_LATEX Prescription Status Apr 2014 Version 1 All contents GS1 Page 63 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name ConsumerSalesCondition MRI Safety Status mRICompatibility CDNA EDE ICEY o Text 1 35 characters GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Notes Use value of PRESCRIPTION_REQUIRED GDSN Definition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required Use value of OTC Code List This is an identification of the compatibility of a trade item for use in the presence of a Magneti
27. FDA GUDID Description Data Entry Notes 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 Data Type amp Length NA Entry List of Values LOV New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below Apr 2014 Version 1 All contents GS1 Page 250 of 256 60 Special Storage Conditions FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates any special storage requirements for the product Ww Z O Public consumerUsageStoragelnstructions Expresses in text the consumer storage and usage instructions of a product which are normally held on the label or accompanying the product This information may or may not be labelled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement or a reference to environment or duration Examples include Refrigerate After Opening Consume within 4 days Keep Out Of Direct Sunlight Store a
28. GS1 GDSN Attribute Name Pair of attributes in combination Enter device description Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Optional Type Alphanum Length 2000 NA NO a tradeltemDescription b additionalTradeltemDescription text Definition a An understandable and useable description of a trade item using brand and other descriptors This attribute is filled with as little abbreviation as possible while keeping to a reasonable length Free form text field this data element is repeatable for each language used and must be associated with a valid ISO language code Field length is 178 characters This should be a meaningful description of the trade item with full spelling to facilitate message processing Retailers can use this description as the base to fully understand the brand flavour scent etc of the specific GTIN in order to accurately create a product description as needed for their internal systems Examples 1 GS1 Brand Base Invisible Solid Deodorant AP Stick Spring Breeze 2 GS1 Brand Laundry Detergent Liquid Compact Regular Instant Stain 1 3 GS1 Brand Hair Colour Liquid Light to Medium Blonde b Additional variants necessary to communicate to the industry to help define the product Multiple variants can be established for each GTIN Data Type a Text Language Qualifier 1 to 178 Characters b Text 1 350 characters GDSN
29. Nanometer clinicalSizeValue C45 20 has this as Depth code C45 A Change Request has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 20 has this as Depth code C52 A Change Request has been submitted to correct Apr 2014 Version 1 All contents GS1 Page 111 of 256 FDA GUDID Code Attribute Code Group GDSN for the FDA Global Unique Device Identifier Database GUDID and netContent clinicalSizeValue height width depth Code Value GS1 GDSN Attribute Sea Description Definition am E re A micrometre is one millionth um Micrometer M E man cerpin Dimension 4H Micrometre of a metre also termed and netConten Micron oe T The international foot is ft_i Feet KEN o nor deni Dimension FOT Foot defined to be equal to 0 3048 and netConten macie Re er An international inch is lini Inch a poe a depth Dimension INH Inches defined to be equal to 25 4 ce millimeters clinicalSizeValue height width depth A yard is It is equal to 3 feet or Iydi Yard and netContent imanen VR Varel 36 inches or 0 9144 meter clinicalSizeValue height width depth a A centimetre is equal to one cm Centimeter and netContent Dimensien eu COMME Me hundredth of a metre dm Decimeter ClinicalSize
30. 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 Apr 2014 Version 1 All contents GS1 Page 168 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 10 Catalog Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated 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 additionalPartyldentification type
31. Yes No YES Public Production Identifier s on Label May 2014 Version 1 1 All contents GS1 Page 40 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID yer Public i z Data Type amp Entry List of New DI i C i 9 Data Element Description Required Length Values LOV Trigger Private Status Lot or Batch en Yes No NO Public Number ruber Th Delete Deletion of entered data ae Eat eat Edit Editing of Manufacturing Add Addition of Yes No NO Public Date Indicates the new data is 7a Delete Deletion Type Serial Number E Add Addition of Yes No NO Public o able and shoul alowed May 2014 Version 1 1 All contents GS1 Page 41 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID j Public A Data Entry TAC Data Type amp Entry List of New DI 7 Data Element Description Notes Required Length Values LOV Trigger Private Status Expiration Date tensa Yes No NO Public by expiration date Delete Deletion of onered dala Boei device states that is allowed anne Sees Indicates the NO device is managed enin alowed Number This Delete Deletion fanaa atures identification pa OO a Yes No aori devices that are O Latex Information Device required ee None NO edit Yes No YES Public to be labeled as containing packaging contains list n
32. 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 a 0 re D Webtool U c en Temporary population until final GDSN deployment groupedProduct value populated in GDSN is KIT Definition Data Type GDSN Required Final Deployment Attribute Name Definition Data Type GDSN Required Population Guidance below Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Text Optional groupedProduct value populated in GDSN is KIT 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 OPTIONAL 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 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 attri
33. code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CMS Clamshell Clamshell Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNA Household Goods Container Wood Household Goods Container Wood Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNB Container MAC ISO LT WGT 8x8x20 Foot Air Container MAC ISO LT WGT 8x8x20 Foot Air Packaging Type GDSN utilizes the code value however GUDID currently Packaging Type Code CNC Container Navy Cargo Transporter Container Navy Cargo Transporter Apr 2014 Version 1 All contents GS1 Page 81 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description where Definition applicable GS1 GDSN Code Value FDA GUDID Code Attribute Code Value GS1 GDSN Attribute Code Group needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the d
34. code value however film around an item or group of items GUDID currently which is heated causing the film to needs a term for the shrink securing the unit integrity code The term in The use of shrunken film to tightly the description field wrap a package or a unit load in at right should be order to bind protect and immobilize passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code STW Stretch Wrap Stretch Wrap In packaging a high code value however tensile plastic film stretched and GUDID currently wrapped repeatedly around an item needs a term for the or group of items to secure and code The term in maintain unit integrity The use of the description field stretch film to tightly wrap a package at right should be or a unit load in order to bind protect passed to the FDA a GUDID Packaging Type GDSN utilizes the Packaging Type Code SV2 SEAVAN SEAVAN A commercial or code value however government owned or leased GUDID currently shipping container which is moved needs a term for the via ocean transportation without code The term in wheels attached and is lifted on and the description field off a ship at right should be passed to the FDA GUDID Apr 2014 Version 1 All contents GS1 Page 99 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the
35. is equal to netContent Volume OZI Fluid ounce UK one thirtieth 1 30 of a UK pint or 28 4130625 millilitres netContent Volume PT Pint The United States dry pint is equal one eighth of a US dry gallon or one half US dry netContent Volume PTD Dry Pint US quarts It is used in the United States but is not as common as the liquid pint The US liquid pint is equal one netContent Volume PTL Liquid pint US eighth of a United States liquid gallon netContent Volume PY Peck Dry U S A US dry quart is equal to netContent Volume Qs Quart Dry 1 32 of a US bushel exactly 1 101220942715 litres netContent Volume QT Quart A US liquid quart exactly Spent equals 57 75 cubic inches netContent Volume QTL Liquid quart US which is exactly equal to 0 946352946 litres netContent Volume UY Fifty Square Feet netContent 2Q Kilo Becquerel kBq is 103 Bq 106 Bai Bq is defined as the activity of a quantity of netContent 4N Megabecquerel radioactive material in which one nucleus decays per second netContent B8 Board netContent BA Bale netContent BD Bundle netContent BG Bag netContent BL Block netContent BO Bottle Apr 2014 Version 1 All contents GS1 Page 152 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition The becquerel symb
36. joules Apr 2014 Version 1 All contents GS1 Page 139 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group netContent Energy D32 Terawatt hour A terawatt hour is 109 kilowat hour or 3 6 petajoules netContent Energy D70 Calorie International Table IT A calorie is 1 100 of the amount of energy required to warm one gram of air free water from 0 C to 100 C at standard atmospheric pressure this is about 4 190 J Its use is archaic having been replaced by the SI unit of energy the joule However in many countries it remains in common use as a unit of food energy In the context of nutrition and especially food labelling the calorie is approximately equal to 4 1868 joules J and energy values are normally quoted in kilojoules kJ and kilocalories kcal netContent Energy E14 Kilocalorie international table A unit of energy equal to 1000 calories netContent Energy GWH Gigawatt hour A gigawatt hour is 109 kilowat hour or 3 6 terajoules netContent Energy JOU Joule A joule is the energy exerted by a force of one newton acting to move an object through a distance of one metre netContent Energy KJO Kilojoule A kilo
37. percentages in which the trade items should be transported Low value for GUDID Code for Storage Type Handling environment humidity transportationMaximumTemperature UoM Numeric Code List The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality transportationMinimumTemperature UoM transportationMaximumTemperature UoM Numeric Code List The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality GUDID Code for Storage Type Handling environment temperature Numeric Code List The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or High value for GUDID Code for Storage Type Handling environment temperature Apr 2014 Version 1 All contents GS1 Page 67 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Data Element GS1 GDSN Attribute Name CDNA EDE ICEY o GDSN Definition GDSN Notes quality The minimum temperature that a trade item can be held below during transport as Low value for GUDID Code for Storage defined by the manufacturer Type Handling environment temperature without affecting product safety or quality a a Numeric Code ist
38. second storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress ureMinimum UoM Pressire 28 Kilogram per A unit of pressure equal to transportationEnvironmentAtmospheri square metre 9 80665 10 05 Bar cPressureMaximum UoM and transportationEnvironmentAtmospheri cPressureMinimum UoM At sea level Earth s atmosphere actually exerts a pressure of 14 7 psi Humans storageEnvironmentAtmosphericPress do not feel this pressure ureMaximum UoM because internal pressure of storageEnvironmentAtmosphericPress Pounds per liquid in their bodies matches ureMinimum UoM Pressure 64 square inch the external pressure If a transportationEnvironmentAtmospheri gauge pressure gauge is calibrated cPressureMaximum UoM and transportationEnvironmentAtmospheri cPressureMinimum UoM to read zero in space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in Apr 2014 Version 1 All contents GS1 Page 144 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID CRIER Code Group Description Definition Group storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress Psig pound force per square inch gauge is a unit of pressure relative to the surro
39. A unit of proportion equal to 0 01 Apr 2014 Version 1 All contents GS1 Page 124 of 256 DISCS DIDE cS Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Description Definition storageHandlingTemperatureMaximu Code Group The Fahrenheit temperature Apr 2014 Version 1 All contents GS1 m UoM scale the freezing point of i a water is 32 degrees storageHandlingT emperatureMinimum Fahrenheit CS and the bolling Uei T t FAH Deges int 212 F at standard transportationMaximumTemperature emperaiute Fahrenheit poin at standar UoM and atmospheric pressure transportationMinimumTemperature placing the boiling and UoM freezing points of water exactly 180 degrees apart Celsius also historically storageHandlingTemperatureMaximu known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM degrees Celsius C and the transportationMaximumTemperature TETPEEUE GZL Dege Caste boiling point 100 C at UoM and standard atmospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingTemperatureMinimum temperature equal to 1 273 16 UoM o
40. Add Addition of Handling NO Public Handling Type storage and new data is Environment handling requirements that are required for the device including temperature entered data is humidity and allowed atmospheric May 2014 Version 1 1 All contents GS1 Page 48 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Pps Public TI Data Type amp Entry List of New DI i r i 9 Data Element Description Required Length Values LOV Trigger Private Status Low Value Indicates the Can edit add or 00 A Low Numeric 6 N A NO Public low value for Value and or delete after Value and or a storage and High Value if Grace Period High Value is handling entering a required if requirements Storage and Storage and Handling Type Handling is E provided temperature High is required humidity etc if Storage and Handling Type is Indicates the Enter a number for NO Public high value for High Value storage and yustenteratieast alowed oie handling one value Low or Delete Deletion requirements Rept Tg of entered data and High Value if ae l DUE 6 characlers Handling Type a is added to the device record temperature humidity etc Unit of Measure r See r NO Public sergeant LOV co conditions of entered data Required if is allowed Storage and _ May 2014 Version 1 1 All contents GS1 Page 49
41. BFT Board Foot A specialized unit of measure for the volume of rough lumber before drying and planing with no adjustments or planed surfaced lumber It is the volume of a one foot length of a board one foot wide and one inch thick Some countries utilize the synonym super foot or superficial foot netContent Volume BLL Barrel US There are varying standards for barrel for some specific commodities including 31 gal for beer 40 gal for whiskey or kerosene and 42 gal for petroleum The general standard for liquids is 31 5 gal or half a hogshead the general standard for dry contents is 7 056 Cubic Inches netContent Volume BN Bulk netContent Volume BP Hundred board foot A unit of volume equal to one hundred board foot netContent Volume BU Bushel netContent Volume BUA Bushel US A bushel is an imperial and U S customary unit of dry volume equivalent in each of these systems to 4 pecks or 8 gallons It is used for volumes of dry commodities not liquids most often in agriculture netContent Volume BUI Bushel UK A bushel is an imperial and U S customary unit of dry volume equivalent in each of these systems to 4 pecks or 8 gallons It is used for volumes of dry commodities not liquids most often in agriculture netContent Volume C3 Centilitre A centilitre is one h
42. Centimeter Dimension CMT Centimetre Outer Diameter and netContent hundredth of a metre UoM Length Size nd 3 PETE 7 a Units of Measure dm Decimeter Doon tonee a ei depth Dimension DMT Decimetre A E ecg one Outer Diameter i Apr 2014 Version 1 All contents GS1 Page 116 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure fm Femtometer clinicalSizeValue A71 20 has this as Outer Diameter e A ange Request has been submitted to correct UoM Length Size oe 3 A clinicalSizeValue height width depth A gt 5 A kilometre is one thousand a km Kilometer nC Dimension KMT Kilometre 1000 metres aa m Meter eal a eee depth pidencion MTR Metre ae Peete Outer Diameter System of Units SI UoM Length Size PRE Se es ae ma Units of Measure mm Millimeter e a depth Dimension MMT Millimetre A aaa a Outer Diameter Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm Nanometer clinicalSizeValue C45 20 has this as Outer Diameter Posi oO A ange Request has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN U
43. Class III 510 k See Historical Background2 for additional information Text Optional exemptFromFDAPreMarketAuthorization Definition Apr 2014 Version 1 All contents GS1 Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety Page 203 of 256 Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Ill 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 pre amendment devices may require a Class III 510 k See Historical Background2 for additional information BOOLEAN OPTIONAL This attribute has a temporary attribute AVP in GDSN exemptFromFDAPreMarketAuthorization It will be deployed into the GDSN Schema in 2016 17 into a final solution This Boolean attribute is used to denote i
44. GDSN Attribute Code Group Value code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BXT Bucket 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 Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CAB Cabinet Cabinet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CAG Cage Cage A container enclosed on at least one side by a grating of wires or bars that lets in air and light Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CAN Can Can A metallic and generally cylindrical container of unspecified size which can be used for items of consumer and institutional sizes Packaging Type
45. GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute GS1 GDSN Code Code Group Code Value GS1 GDSN Attribute Value where Definition applicable needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code FWR Forward Reel Forward Reel code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GBG Bag In Box or BIB Bag In Box or BIB is a type of code value however container for the storage and GUDID currently transportation of liquids It consists of needs a term for the a strong bladder usually made of code The term in aluminium PET film or other plastics the description field seated inside a corrugated at right should be fibreboard box The box and internal passed to the FDA bag can be fused GUDID Packaging Type GDSN utilizes the Packaging Type Code GBR Brick Brick A rectangular shaped code value however stackable package designed GUDID currently primarily for liquids such as juice or needs a term for the milk code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GGT Gable Top Gable Top A rectangular shaped code value however non s
46. GUDID Packaging Type Code BOX Box Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BRC Bracing Bracing Material or devices used to hold articles or sections of loads in position to prevent shifting during transportation Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BRG Barge Barge Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BSK Basket or hamper Basket or hamper A semi rigid container usually open at the top traditionally used for gathering shipping and marketing agricultural products Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the Packaging Type Code BXI Box with inner Box with inner container container Apr 2014 Version 1 All contents GS1 Page 78 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description where Definition applicable FDA GUDID Code Attribute GS1 GDSN Code Code Value GS1
47. GUDID currently needs a term for the code The term in the description field Packaging Type Code TNK Tank Tank Apr 2014 Version 1 All contents GS1 Page 100 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute CRARCIDRIN KO Code Value Value GS1 GDSN Attribute where Definition applicable Code Group at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TRC Tierce Tierce Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TRK Trunk and Chest Trunk and Chest Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TRU Truck Truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TRY Tray Tray A shallow container whic
48. Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required 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 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 Apr 2014 Version 1 All contents GS1 Page 164 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 7 Company Physical Address FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Private GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required 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 Once published a 7 day grace period begi
49. H79 French gauge The French scale most correctly abbreviated as Fr but also often abbreviated as FR or F is commonly used to measure the catheter size Circumference is in millimeters in which 1 Fr 0 33 mm in diameter In the French Gauge 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 Apr 2014 Version 1 All contents GS1 Page 108 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Group Currently no Circumference and netContent GDSN or UN Recommendation UoM Gauge Needle 20 Value for FDA Units of Measure G Gauge clinicalSizeValue PENDING GUDID UoM A Needle Gauge Change Request has been submitted to correct UoM Length Size 3 TEC J The international foot is o of ene ft_i Feet Same cele oe ng casin Dimension FOT Foot defined to be E to 0 3048 ircumference meters UoM Length Size i F Yun An international inch is Units of Measure in_i Inch Se eee ee ea Sean Dimension INH Inches defined to be eq
50. Package Type Quantity per Package 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 the quantity of the child trade item GUDID Contains DI Package which is contained in the GTIN GUDID Package DI Number See the example below This GDSN attribute references the hierarchy level which is the next level below or Child of the globalTradeitemNumber GUDID Package DI Number See the example below Apr 2014 Version 1 All contents GS1 Page 189 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID In GDSN the following is provided Hierarchy Number 1 ChildTradeltem glob quantityofNextLow globalTradeitemNumber tradeltemUnitDescriptor amare a Nimbe Pene maaien Notes 2061414111111c CASE 1061414111111c 5 5 cartons in a case 1061414111111c PACK_OR_INNER_PACK 0061414111111c 4 4 boxes in a carton 0061414111111c BASE_UNIT_OR_EACH N A N A 1 Box of Gloves Hierarchy Number 2 3 ChildTradeltem glo quantityofNextLo D E e aia balTradeltemNumb werLevelTradelte Notes er m 4061414111111c CASE 3061414111111c 2 2 cartons in a case 3061414111111c ba ae 0061414111111c 10 10 boxes in a carton BASE_UNIT_OR_EAC 0061414111111 c H N A N A 1 Box of Gloves This is converted to the followin
51. Percent unto HR Om egua UoM and cane transportationHumidityMinimum UoM A cubic inch is the volume of a netContent Volume INQ Cubic inch cube of side length one inch 0 254 m netContent Volume CU Cup Apr 2014 Version 1 All contents GS1 Page 129 of 256 i BY WC10 B D relo o Attribute Code Code Value Group GS1 GDSN Attribute netContent GS1 GDSN Code Group Volume OZA Description Fluid ounce US GDSN for the FDA Global Unique Device Identifier Database GUDID Definition A fluid ounce US is equal to one sixteenth 1 16 of a US pint or 29 5735295625 millilitres netContent Volume GLL Gallon US The U S liquid gallon is legally defined as 231 cubic inches and is equal to exactly 3 785411784 litres or about 0 133680555 cubic feet netContent Volume PTI Pint UK A pint UK is equal to 1 8 Gallon UK used primarily as a measure for beer and cider when sold by the glass netContent Volume QTD Quart US dry A US dry quart is equal to 1 32 of a US bushel exactly 1 101220942715 litres netContent Volume CLT centilitre 10 m netContent netContent Volume Volume DLT K6 Decilitre Kilolitre A decilitre is one tenth 1 10 of a litre A kilolitre is one thousand 1000 litres netContent Volume LTR Li
52. Required OPTIONAL Apr 2014 Version 1 All contents GS1 Page 171 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Population Guidance below These two attributes will be concatenated together into one value when provided to the GUDID The concatenation of these two descriptions will provide the best description available as some labellers might have used only one of the two fields If only one of the attributes is populated in GDSN only that value will be populated in the GUDID Apr 2014 Version 1 All contents GS1 Page 172 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 12 DI Record Publish Date mmddyy FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Indicates the date the DI Record gets published and is available via Public Search Drop down is for D 28 fe o o lt i Public Temporary population until final GDSN deployment Attribute Name Definition Data Type GDSN Required Population Guidance below Apr 2014 Version 1 All contents GS1 Page 173 of 256 Apr 2014 Version 1 GDSN for the FDA Global Unique Device Identifier Database GUDID All contents GS1 Page 174 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 13 Commercial Distributi
53. Type Text GDSN Required Optional Final Deployment Attribute Name groupedProduct value populated in GDSN is COMBINATION 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 Data Type Code List GDSN Required OPTIONAL 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_AND_ COMBINATION will populate a value of TRUE for the GUDID attribute Combination Product Any other value or when no value is provided for the GDSN attribute will populate a value of FALSE for the GUDID attribute Combination Apr 2014 Version 1 All contents GS1 Page 201 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID This attribute will be used to provide several sets of information and as such may be repeated GUDID attributes using this group of attributes 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
54. Uniti o aime o 0 aee 2 In telecommunications and computing bitrate sometimes written bit rate data rate or as a variable R or fb is the netContent Time B10 Bit per second number of bits that are conveyed or processed per unit of time The bit rate is quantified using the bits per second bit s or bps unit A millisecond from milli and are second abbreviation ms is a netContent Time C26 Millisecond thousandth 1 1000 of a second A day is one three hundreds mionn Time BA PENS and sixty fifth 1 365 of a year A day is one three hundreds Wesel gine DAY Days and sixty fifth 1 365 of a year An hour is a unit of measurement of time of the netContent Time HUR Hour duration of 60 minutes or 3600 seconds It is 1 24 of a median Earth day Minute unit of A minute is a unit of time netContent Time MIN equal to 1 60th of an hour or time 60 seconds Unit of time equal to 1 12 of a netContent Time MON Month year of 365 25 days Apr 2014 Version 1 All contents GS1 Page 148 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group netContent Time SEC Second unit of time A second is a unit of time equal to 1 60th of a minute netContent Time WEE Week A week is a time unit equal to seven days netContent Volume
55. Version or Model Number Catalog Number Secondary 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 All contents GS1 Page 183 of 256 20 Package DI Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Apr 2014 Version 1 GDSN for the FDA Global Unique Device Identifier Database GUDID IN A O Public Zz globalTradeltemNumber hierarchy levels where isTradeltemABaseUnit is FALSE A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Identifier 14 digits DEPENDENT not populated where isTradeltemABaseUnit is TRUE All contents GS1 Page 184 of 256 GDSN for the FDA Global Unique Device Population Guidance below The GUDID Package attributes are populated as a group and can not elements in the message These attribute
56. a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected Such change or modification could relate to the design material chemical composition energy source manufacturing process or intended use Category code based on alternate classification Code value managed by GMDN Only additionalClassificationCode Text 1 15 characters schema chosen in addition to the GMDN Code is provided to the EAN UCC classification GUDID schema additionalClassificationAgency Code List Use code 35 Apr 2014 Version 1 All contents GS1 Page 61 of 256 FDA GUDID Data Element Definition GS1 GDSN Attribute Name GDSN Data Type GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition GDSN Notes FDA will populate based on the FDA Product Code SPL Name FDA Preferred Term Code additionalClassificationCategoryCode Text 1 15 characters Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Code value managed by GMDN FDA Only 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 Device Characteristics For Single Use manufacturerDecl
57. additionalTradeltemldentificationType Code List Use code of HIBCC or ICCBBA an alternative to the Global Trade Item Number Alternative means to the additionalTradeltemldentificationValue Code List Global Trade Item Number to identify a trade item Package DI Can add Package Configuration after Grace Period but cannot delete or edit Package Configurations entered prior to the end of the Grace Period globalTradeltemNumber use hierarchy to obtain parent child information Numeric 14 Characters EAN UCC numbering structures will be used for the identification of trade items All of them will be considered as 14 digit Global Trade Item Number GTIN Must be present to enable data to be presented to trade item catalogue Must be submitted by the owner of the data who may be the original manufacturer the importer the broker or the agent of the original manufacturer This field is mandatory within the Global Data Synchronization work process FDA GUDID contains the lowest level of the GDSN hierarchy as its primary Higher levels of packaging are only referenced as package levels See additional guidance below for more details totalQuantityOfNextLowerLevelTradelte m Numeric This represents the Total quantity of next lower level trade items that this trade item contains childGTIN Numeric 14 Characters A particular Global trade item Number a numerical value used to uniquely identify a
58. appropriate issuing agency code value for GUDID This attribute is required if a value is populated for additionalTradeltemldentificaton 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 not be changed Many of the data elements are locked and can no longer be edited 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 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 Apr 2014 Version 1 All contents GS1 Page 181 of 256 19 Secondary DI Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance GDSN for the FDA Global Unique Device Identifier Database GUDID ia Public additionalTradeltemldentificaton value Alternative means to the Global Trade Item Number to OPTIONAL Multiple Occurrence The GS1
59. code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code VP Vacuum Packed Vacuum Packed Packaging in containers either rigid or flexible from which substantially all gases have been removed prior to final sealing of the container Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code VPK Van Pack Van Pack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code WHE On Own Wheel On Own Wheel Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code WLC Wheeled Carrier Wheeled Carrier Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code WRP Wrapped Wrapped 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 shri
60. description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition Tube A cylindrical container sealed on one end that could be closed with a cap or dispenser on the other end Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TBN Tote Bin Tote Bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TKR Tank Car Tank Car Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TKT Tank Truck Tank Truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TLD Intermodal Trailer Container Load Rail Intermodal Trailer Container Load Rail Packaging Type GDSN utilizes the code value however
61. drop down LOV Webtool Edit Rules After Grace Period None NO edit add or delete are allowed Required Optional Data Type amp Length NA Entry List of Values LOV GS1 HIBCC ICCBBA NHRIC New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name additionalTradeltemldentificaton type Definition Type of the identification system that is being used as an alternative to the Global Trade Item Number Data Type Code List GDSN Required OPTIONAL Multiple Occurrence 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 provide data to the GUDID a GTIN using GS1 as the issuing agency can not be a secondary DI However the item might have another issuing agency s item number standard in use Using the GDSN attribute additionalTradeltemldentificaton type these other issuing agency identifiers can be provided Currently the GDSN attribute has code values for other issuing agencies which would have an associated additionalTradeltemldentificaton value provided to the GUDID If a value is populated through GDSN for an issuing agency using the attribute additionalTradeltemldentificaton type it will be provided to the GUDID as a secondary DI The codes available for the Secondary DI Issuing Agency are HIBC and ICCBBA The population of one of these additionalTradeltemldentificaton type values will denote the
62. entry of handling equipment on each of its four sides Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PAL Pail Pail Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PAT Pallet 2 way Pallet 2 Way A pallet that permits entry of handling equipment on opposing two of its four sides Apr 2014 Version 1 All contents GS1 Page 93 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition Packed not otherwise specified Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PCS Pieces Pieces Packaging Type GDSN utilizes the code v
63. express the density or weight of all types of paper paperboard and fabric e g Ree Ounces per 20 OZ or 20 Weight denim grossWeight and netContent Mass ON square yard has an area density of 20 oz yd2 The term density here is used somewhat incorrectly as density is mass by volume More precisely it is a measure of the area density areal density or surface density A unit of mass with several definitions the most grossWeight and netContent Mass ONZ Ounce commonly used of which are equal to approximately 30 grams ie Pounds grossWeight and netContent Mass RE Equivalent grossWeight and netContent Mass PG Pound Gross grossWeight and netContent Mass PN Pounds net grossWeight and netContent Mass X_NGM Nanogram A nano gram IS DD giem a a billionth of a gram netContent Power KWT Kilowatt Akona sonoinous and 1000 watts Apr 2014 Version 1 All contents GS1 Page 143 of 256 FDA GUDID Code Attribute Code Code Value Group GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN GS1 GDSN Attribute Description Definition Code Group A unit of power defining the rate of energy transferred or consumed when a current of netContent Power MAW Megawatt 1000 amperes flows due to a potential of 1000 volts at unity power factor A watt is a derived unit of power one watt is equivalent netContent Power WTT Watt to 1 joule J of energy per
64. 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 Apr 2014 Version 1 All contents GS1 Page 210 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 34 Product Code FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV FDA Product Code list New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalClassificationAgencyName Code 43 for US FDA Product Code b additionalClassificationCategoryCode Definition a Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated 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 additionalClassificationAgencyName The
65. humidity in percentages that the goods should be stored in GUDID Code for Storage Type Storage environment humidity Apr 2014 Version 1 storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum UoM Numeric Code List The maximum humidity in percentages that the goods should be stored in High Value for GUDID Code for Storage Type Storage environment humidity Numeric Code List The minimum humidity in percentages that the goods should be stored in Low Value GUDID Code for Storage Type Storage environment humidity All contents GS1 Page 65 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name storageHandlingTemperatureMaximum UoM CDNA EDECEM o Numeric Code List GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value storageHandlingTemperatureMinimum UoM Numeric Code List The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value GDSN Notes GUDID Code for Storage Type Storage environment temperature storageHandlingTemperatureMaximum UoM Numeric Code List The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure
66. in the description field at right should be passed to the FDA GUDID Packaging Type Code ENV Envelope Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code EPR Edge Protection Edge Protection A right angle piece placed over the outermost perimeter edges of a container to distribute pressure and prevent collapse or cutting from banding strapping or handling Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FIR Firkin Firkin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FLO Flo bin Flo bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FRM Frame Frame Packaging Type GDSN utilizes the code value however GUDID currently Packaging Type Code FSK Flask Flask Apr 2014 Version 1 All contents GS1 Page 86 of 256
67. in space At sea level Earth s atmosphere storageEnvironmentAtmosphericPress actually exerts a pressure of ureMaximum UoM 14 7 psi Humans do not feel storageEnvironmentAtmosphericPress this pressure because internal Pos a tosh psi Pound per Square ureMinimum UoM Pressure 80 ence f pressure of liquid in their Inch transportationEnvironmentAtmospheri Abselitte bodies matches the external cPressureMaximum UoM and pressure If a pressure gauge transportationEnvironmentAtmospheri is calibrated to read zero in cPressureMinimum UoM space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in Apr 2014 Version 1 All contents GS1 Page 119 of 256 FDA GUDID Code Attribute Code Group UoM Pressure Units of Measure Pressure Code Value Hz Hertz GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN GS1 GDSN Attribute Description Code Group netContent Frequency HTZ Hertz Definition A unit of frequency defined as the number of complete cycles per second it is the basic unit of frequency in the International System of Units SI UoM Pressure Units of Measure Pressure kPa KiloPascal Currently no GDSN Value for FDA GUDID UoM UN Recommendation 20 has this as code KPA A Change Request has been s
68. is the value below which the trade item should not be subjected b The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected c The minimum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below The GDSN attributes are pairs of attributes with a minimum and a maximum value This provides a range of applicability for the device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name 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 The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes E te GDSN Attributes Storage environment storageHandlingTemperatureMaximum temperature storageHandling TemperatureMinimum a storageHandlingHumidityMaximum Storage environment humidity storageHandlingHumidityMinimum Storage environment storageEnvironmentAtmosphericPressureMaximum atmospheric pressure storageEnvironmentAtmosphericPressureMinimum AVP Handling environment transportationMaximumT emperature temperature transportationMi
69. 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 manufacturer Each manufacturer should have an internal process to manage the data required by the regulator This includes May 2014 Version 1 1 All contents GS1 Page 11 of 256 Draft pending IP Review and Ratification 1 6 1 7 GDSN for the FDA Global Unique Device Identifier Database GUDID e data quality checks and procedures e data management process and policies e enterprise wide data governance policies e roles and responsibilities which outline who has the authority to create modify and approve the data GS1 strongly recommends that each manufacturer 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
70. necessary to communicate to 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 The schema uses common library component as shown in the GDD Max Size field For the business requirements for item please use the specific definition of this data type and field 1 350 CONCATENATION tradeltemDescription and additionalTradeltemDescription tradeltemDescription Text 1 to 178 characters An understandable and useable description of a trade item using brand and other descriptors This attribute is filled with as little abbreviation as possible while keeping to a reasonable length Free form text field this data element is repeatable CONCATENATION tradeltemDescription and additionalTradeltemDescription Apr 2014 Version 1 All contents GS1 Page 55 of 256 FDA GUDID Data Element Commercial Distribution GS1 GDSN Attribute Name CDNA EDE ICEY o GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition GDSN Notes DI Record Publish Date mm ddiyyyy uDIDPublishDate Date CCYY MM DDTHH MM SS 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 n
71. no longer be edited Apr 2014 Version 1 All contents GS1 Page 202 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 31 Device Exempt from Premarket Authorization FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Device is exempt from FDA Premarket regulations or a pre amendment device s m 5 Temporary population until final GDSN deployment exemptFromFDAPreMarketAuthorization Definition Data Type GDSN Required Final Deployment Attribute Name 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 Ill 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 pre amendment devices may require a
72. of 256 a a a Special Storage Conditions Indicates any special storage requirements for the device Sterilization Method GDSN for the FDA Global Unique Device Identifier Database GUDID NO Public Device Packaged as Sterile Indicates the medical device is free from viable microorganisms ea O ae n YES Public May 2014 Vers ion 1 1 All contents GS1 Page 50 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID eta Public AA Te a Data Entry Ao Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger Maley Requires Indicates that the Choose Yes No YES Public Sterilization device requires from the drop down Prior to Use sterilization prior list to use Ta are independent of about the davis before it can safely of whether the Required m Yes No Sterilization Indicates the NO Public Method method s of from the drop down sterilization that Lov can be used for Only applicable it this device naan arts NA Sterilization Prior May 2014 Version 1 1 All contents GS1 Page 51 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID May 2014 Version 1 1 All contents GS1 Page 52 of 256
73. pa NO Public Name associated with the three letter Product Code Product Code most are auto populated fields AU NA NA ae FDA Listing FDA Listing Number Add Addition of NO Private Number assigned by FDA new data is during allowed Registration and Unless device NA Listing to all devices in is an HCT P commercial pers kit or IVD with May 2014 Version 1 1 All contents GS1 Page 38 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Fp aes Public fern z Data Type amp Entry List of New DI i r i 9 Data Element Description Required Length Values LOV Trigger Private Status distribution ee regardless of pre market authorization requirements per 21 CFR 807 28 f Enter all applicable NO Private GMDN Preferred Tor PT Code 5 GMDN Code FDA a set Must enter GMDN Eare podie or enter both codes categorzaton erans ete ios cebu grees ry seeectenet Eoropie S Codes Enter the 4 letter code May 2014 Version 1 1 All contents GS1 Page 39 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID populated fields NA NA whose information Definition NO Public able to be changed directly most are auto element Device Characteristics For Single Use Choose Yes No Choose Yes No
74. progression succussing or triturating one 1 part of the preceding attenuation to 99 parts of the vehicle and represent the following proportions of active principle i e dried medicinal substance 2CH 10 4 3CH 10 6 Apr 2014 Version 1 All contents GS1 Page 133 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID CRIER Code Group Code Value Description Definition Group netContent Count CV Cover netContent Count D63 Book A unit of count defining the number of books book set of items bound together or written document of a material whole netContent Count DZ Dozen A unit of count defining the number of units in multiples of 12 netContent Count DZN Dozen A unit of count defining the number of units in multiples of 12 netContent Count E27 Dose A unit of count defining the number of doses dose a definite quantity of a medicine or drug netContent Count E34 Gigabyte A unit of information equal to 109 bytes netContent Count E35 Terabyte A unit of information equal to 1012 bytes netContent Count E37 Pixel A unit of count defining the number of pixels pixel picture element netContent Count E39 Dots per inch
75. 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 can not be edited or deleted Apr 2014 Version 1 All contents GS1 Page 240 of 256 56 Storage and Handling Type FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates storage and handling requirements that are required for the device including temperature humidity and atmospheric pressure i CV for Storage Conditions NO Public Attribute Name LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Name a storageHandlingTemperatureMaximum storageHandlingT emperatureMinimum storageHandlingHumidityMaximum b c d storageHandlingHumidityMinimum e transportationMaximumTemperature f transportationMinimumTemperature Definition a The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value b The minimum temperature at which the trade item can be stored This uses a measurement consisting of a
76. the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID Cis C Bio KO 5 Value Code Description where applicable Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code COR Core Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CRD Cradle Cradle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CRF Corner Reinforcement Corner Reinforcement Usually in boxes or crates additional material or components attached to adjacent panels to add support or prevent crushing or separation Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CRT Packaging Type GDSN utilizes the code value however GUDID currently needs a t
77. the code value however GUDID currently Packaging Type Code PRT Partitioning Partitioning The proceeds of applying separators or dividers Apr 2014 Version 1 All contents GS1 Page 95 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description GS1 GDSN Code ahere Definition Value FDA GUDID Code Attribute Code Value GS1 GDSN Attribute Code Group needs a term for the code The term in the description field at right should be passed to the FDA GUDID applicable Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PUN Punnet Punnet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PWT Plastic Wrapped Tray Plastic Wrapped Tray Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code RAL Rail Semiconductor Rail Semiconductor Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description
78. the FDA Global Unique Device Identifier Database GUDID 37 Code SPL Name GMDN Preferred Term Code and FDA Preferred Term Code FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length wa Entry List of Values LOV New DI Trigger NO Public Private Status Private GS1 GDSN Attribute Name Pair of attributes in combination a additionalClassificationAgencyName Code of 35 for Global Medical Devices Nomenclature GMDN b additionalClassificationCategoryCode Definition Apr 2014 Version 1 All contents GS1 Page 216 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID a Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This repeatable set of attributes will allow for the population of a for the device This can be accomplished by the population of the code value 35 in the GDSN attribute additionalClassificationAgencyName The actual GMDN Code can then be populated us
79. 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 Data Type Numeric GDSN Required OPTIONAL Final Deployment Attribute Name clinicalSizeValue 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 Data Type Measurement numeric amp UoM qualifier GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeValue It will be deployed into the GDSN Schema in 2016 17 into a final 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 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 Apr 2014 Version 1 All contents GS1 Page 236 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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
80. trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain In this context the GTIN for the current item which is a child item of another item packaging T ypeCode Text 1 3 characters The code identifying the type of package used as a container of the trade item packagingTypeDescription Apr 2014 Version 1 Text 1 70 characters System generated text description of the type of packaging used for the trade item All contents GS1 Page 57 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name discontinuedDate contactType communicationChannelCode GDSN Data Type DateTime GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition Communicate the date on which the trade item is no longer to be manufactured Allows the reuse of the GTIN after 48 months with the explicit exception of Apparel being 30 months and the implicit exception for specialty products e g steel beams GDSN Notes At the package DI level The general category of the Value populated for the contact Code List ie ane es item information is CUSTOMER SUPPORT Code List Means used to communicate Value populated for the support contact with another
81. will not contain the Production Identifiers i e Expiration Date Batch Lot Number Serial Number or others 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 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
82. 1 9 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 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 organization 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 manufacturer 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 e Executive Internal sponsors of the Master Data Management process within an organization executive management e 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 U
83. 9 of 256 FDA GUDID Code GDSN for the FDA Global Unique Device Identifier Database GUDID Attribute Code Code Value GS1 GDSN Attribute a rae Description Definition Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm Nanometer clinicalSizeValue C45 20 has this as Circumference es A ange Reques has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 20 has this as Circumference i ae A ange Reques has been submitted to correct UoM Length Size ae 7 E E See A micrometre is one millionth Units of Measure um Micrometer asta arts Poems depth Dimension 4H Micrometre ofa oe also termed Circumference icron UoM Length Size oy 7 EAE The international foot is Units E ft_i Feet Bene aes e ai depth Dimension FOT Foot defined to be a to 0 3048 ept meters UoM Length Size ov T An international inch is Units of Measure in_i Inch E e aga depth Dimension INH Inches defined to be equal to 25 4 Depth millimeters UoM Length Size IR E T y ee clinicalSizeValue height width depth A yard is It is equal to 3 feet or miniti A s WOSA and netContent Dimension VRD Yard 36 inches or 0 9144 meter ep UoM Length Size re Ree eee 3 clinicalSizeValue
84. A peck is an imperial and U S customary unit of dry volume equivalent in each of these systems to 2 gallons 8 dry quarts or 16 dry pints netContent Volume G24 Tablespoon Tablespoon 1 2 fluid ounces 3 teaspoons 15 millilitres netContent Volume G25 Teaspoon Teaspoon 1 6 fluid ounces or 5 millilitres netContent Volume GA Gallon netContent Volume GLI Gallon UK The imperial UK gallon was legally defined as 4 54609 litres netContent Volume HLT Hectolitre A hectolitre is one hundred 100 litres netContent Volume LT Litre A litre is defined as a special name for a cubic decimetre 1 L 1 dm3 103 cm3 netContent Volume ML Millilitre One thousandth of a litre 0 001 netContent Volume MMQ Cubic millimetre A cubic millimetre is the volume of a cube of side length one millimetre 0 001 m Apr 2014 Version 1 All contents GS1 Page 151 of 256 FDA GUDID Code GDSN for the FDA Global Unique Device Identifier Database GUDID Attribute Code Code Value GS1 GDSN Attribute ee CDSN coce Description Definition G Code Group Value roup A cubic metre is the volume of netContent Volume MTQ Cubic metre a cube of side length one metre A fluid ounce UK
85. D 57 Low Value SPL Name Storage and Handling Low Value FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Indicates the low value for storage and handling requirements Public LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Name a storageHandlingTemperatureMinimum b storageHandlingHumidityMinimum c transportationMinimumTemperature Definition a The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value b The minimum humidity in percentages that the goods should be stored in c The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironmentAtmosphericPressureMinimum b transportationEnvironmentAtmosphericPressMinimum c transportationMaximumHumidityMinimum Apr 2014 Version 1 All contents GS1 Page 244 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Definition a The minimum atmospheric pressure in which the item should be stored to remain usable This value
86. DI regulation e 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 Roles and Responsibilities 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 organization 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 organization ranging from manufacturing to product management to regulatory affairs Which model applies to a particular organization depends on many factors such as organizational structure size and policies related to corporate versus division autonomy and perhaps even legal incorporation of the various divisions which make up the organization There are many models for establishing and documenting Roles and Responsibilities The first step should be to determine if your organization 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 e R Responsible owns th
87. DID Description Organization accredited by FDA to operate a system for the issuance of UDIs Data Entry Notes Choose a value from the drop down LOV Webtool Edit Rules After Grace Period Cannot edit add or delete after the Grace Period Required Required Data Type amp Length NA Entry List of Values LOV GS1 HIBCC ICCBBA New DI Trigger YES Public Private Status PUBLIC GS1 GDSN Attrioute Name N A LOGICAL POPUALTION Definition N A Data Type N A GDSN Required 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 and can no longer be edited Apr 2014 Version 1 All contents GS1 Page 157 of 256 2 Primary DI FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID lt m n
88. DS Network for all Data Pools to use in the submission and registration of the manufacturer s medical device product data May 2014 Version 1 1 All contents GS1 Page 10 of 256 Draft pending IP Review and Ratification 1 3 5 1 4 1 5 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 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 illustration below provides a basic cross reference between UDI terms and the corresponding GS1 standard GS1 Standards Unique Device Identification H Product Identification UDID GDSN Data Elements linked to the Device Identifier Attributes mapped to each UDID data element DI H GTIN Device Identifier DI H Global Trade I
89. DSN Required Optional Final Deployment Attribute Name _isTradeltemExemptFromDirectPartMarking Definition Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the Data Type Boolean GDSN Required Optional 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 a temporary attribute AVP in GDSN It will be deployed into the GDSN Schema in 2016 17 into a final solution Apr 2014 Version 1 All contents GS1 Page 177 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status s m 5 GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance below LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of a value of DIRECT_PART_MARKINGC in GDSN Attribute additionalTradeltemldentification type 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 attr
90. DSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group A unit of count defining the Milliequivalence number of milligrams of caustic potash potassium hydroxide per gram netContent KO per gram of of product as a E p of the product concentration of potassium hydroxide in the product K Centesimal Scale of Attenuation One millilitre 1 0 ml of the first centesimal liquid attenuation 1C or one gram 1 0 g of the first centesimal trituration 1C represents 0 01 gram 10 0 mg of the dry crude medicinal substance Subsequent liquid netContent KVN Korsakovian K or solid attenuations are made by serial progression succussing or triturating one 1 part of the preceding attenuation to 99 parts of the vehicle and represent the following proportions of active principle i e dried medicinal substance 2CH 10 4 3CH 10 6 Milliequivalents of solute per liter of solvent or milliNormal where mEq L mN This is especially common for mEq or measurement of compounds netContent MEG milliequivalents in biological fluids for instance the healthy level of potassium in the blood of a human is defined between 3 5 and 5 0 mEg L netContent MX Uae netContent NT Trailer netContent PA Pail netContent PFU Plaque Folate Plaque Forming unit s unit s netContent PH Pack netContent PK Package netContent PL Pal
91. Database GUDID b Text Multiple Occurrence GDSN Required OPTIONAL however if one is populated the other must also be populated Population Guidance below This should only be populated if a there is a Direct Part Mark on the Device AND b the DI used in the Direct Part Mark is NOT 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 additionalTradeltemldentificaton type with a value of DIRECT_PART_MARK will allow for the appropriate additionalTradeltemldentificaton value to be populated This attribute pair can be repeated for as many DPM DI s the item might have The value populated in the GDSN attribute additionalTradeltemldentificaton type attribute associated with the additionalTradeltemldentificaton value DIRECT_PART_MARK is what will be populated in the GUDID 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 Version or Model Number Catalog Number Secondary DI Number and FDA Listing Number Apr 2014 Version 1 All contents GS1 Page 180 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 18 Secondary DI Issuing Agency FDA GUDID Description Name of Secondary DI Issuing agency Data Entry Notes Choose a value from the
92. EAN UPC GS1 128 GS1 DataMatrix Bar Code symbologies EAN 13 01 10857674002017 10 1152KMB 4 512345 678906 gt GS1 DataMatrix aoe 000000 00 17 141120 10 1234AB 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 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 gs1 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 manufacturer and the data recipients In addition the U S FDA Global UDI database is identified by GLN 1100001017041 within the GDS Network This unique identification ensures that there is a single and unique global identification of the U S FDA GUDID within the entire G
93. Expresses in text the consumer storage and usage instructions of a product which are normally held on the label or accompanying the product This information may or may not be labelled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement or a reference to environment or duration Examples include Refrigerate After Opening Consume within 4 days Keep Out Of Direct Sunlight Store at an Ambient Text 1 to 1000 Temperature Store ina characters Clean Cool Dry Place Store Away From Sunlight Strong Odours and Chemicals Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight and Freezing Temperatures Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight Before opening store at 5 C 30 C After Opening Keep Refrigerated 5 C and Consume Within 48 hours Drink Chilled Store in a Cool Dry Place Refrigerate After Opening Can Be Kept in the Fridge For 3 Months consumerUsageStoragelnstructions Sterilization Method Apr 2014 Version 1 All contents GS1 Page 68 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Data Element GS1 GDSN Attribute Name CDNA EDE ICEY o GDSN Definition GDSN Notes Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it
94. FDA Global Unique Device Identifier Database GUDID 28 Human Cell Tissue or Cellular or Tissue Based Product HCT P FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below 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 ul Public does TradeltemContainHumanTissue 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 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 Apr 2014 Version 1 All contents GS1 Page 198 of 256 29 Kit FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates that the device is a convenience combination in vitro diagnostic IVD or medical procedure kit Kits
95. GDSN for the FDA Global Unique DIA O C ADELE ERE 16 8 1B Implementation Guide Version 1 1 May 2014 Draft pending IP Review and Ratification May 2014 Version 1 1 GDSN for the FDA Global Unique Device Identifier Database GUDID All contents GS1 Page 2 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 AISBL All rights reserved GS 1 Global Office Avenue Louise 326 bte 10 B 1050 Brussels Belgium Disclaimer GS1 under its IP Policy seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in the Work Group that developed this GDSN for the FDA Global Unique Device Identifier Database GUDID to agree to grant to GS1 members a royalty free license or a RAND license 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 licensing obligations of GS1 Moreover the agreement to grant licenses 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
96. GDSN for the FDA Global Unique Device Identifier Database GUDID 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 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 Apr 2014 Version 1 All contents GS1 Page 53 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition De
97. GUDID Packaging Type Packaging Type Code MS2 MSCVAN MSCVAN A commercial leased or Government owned shipping container controlled by the Military Sealift Command GDSN utilizes the code value however GUDID currently Packaging Type Packaging Type Code MXD Mixed Mixed Apr 2014 Version 1 All contents GS1 Page 92 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description where Definition applicable GS1 GDSN Code Value FDA GUDID Code Attribute Code Value GS1 GDSN Attribute Code Group needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code NOL Noil Noil Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PA Packet Packet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PAF Pallet 4 Way Pallet 4 Way A pallet that permits
98. General Specifications stipulate that a Trade Item can only have one GTIN As the GTIN is the primary Dl for an item using GDSN to provide data to the GUDID a GTIN using GS1 as the issuing agency can not be a secondary DI However the item might have another issuing agency s item number standard in use Using the GDSN attrioute additionalTradeltemldentificaton value these other issuing agency identifiers can be provided If a value is populated through GDSN for an issuing agency using the attribute additionalTradeltemldentificaton type it will be provided to the GUDID as a secondary DI The population of one of the additionalTradeltemldentificaton type values Apr 2014 Version 1 All contents GS1 Page 182 of 256 Apr 2014 Version 1 GDSN for the FDA Global Unique Device Identifier Database GUDID for an issuing agency will denote the appropriate issuing agency code value for GUDID for which the value populated in this attribute is relevant This attribute is required if a value is populated for additionalTradeltemldentificaton type 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 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
99. II 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 additionalClassificationCategoryAgency Code List Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields AVP exemptFromFDAPreMarketAuthorization External Code managed by FDA Apr 2014 Version 1 All contents GS1 Page 59 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name CDNA EDE IEEE o GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition are populated additionalClassificationCategoryCode Text 1 15 characters Category code based on alternate classification schema chosen in addition to EAN UCC cl
100. Maximu known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM degrees Celsius C and the transportationMaximumTemperature Temperature GZL Degree Celsius boiling point 100 C at UoM and standard atmospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart Apr 2014 Version 1 All contents GS1 Page 127 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute eet or Description Definition Group storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingTemperatureMinimum temperature equal to 1 273 16 UoM of the absolute temperature of transportationMaximumTemperature Temperi KEIL Neila the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum UoM transportationHumidityMaximum Proportion P1 Percent Auta P equal to UoM and 01 transportationHumidityMinimum UoM storageHandlingTemperatureMaximu The Fahrenheit temperature m UoM scale the freezing point of storageHandlingTemperatureMinimum water is 32 degrees Fahrenheit F and the boiling
101. Page 160 of 256 4 Unit of Use DI Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID An identifier assigned to an individual medical device when a UDI is not labelled 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 AN Public fDAUnitOfUseGTIN GTIN of a unit of use as defined by the FDA This is a lower level unit which is contained in the Trade Item GTIN A Z If the Device Count is greater than 1 gt 1 the unit of use DI is required for population in the GUDID This attribute is a temporary attribute AVP in GDSN It will be deployed into the GDSN Schema in 2016 17 into a final solution This final solution will be part of the GDSN solution for Level below Each LBE Apr 2014 Version 1 All contents GS1 Page 161 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 5 Labeler DUNS Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Wl Public Private Status Private GS1 GDSN Attr
102. S Sample per second A unit of count defining the number of samplings takes during a period of time netContent Count 252 Usage e g in laundry 24 usage netContent Currency DO Dollars U S netContent Density 23 Grams Per Cubic Centimetre Grams Per Cubic Centimetre netContent Density GM Gram per square metre In the metric system the density of all types of paper paperboard and fabric is expressed in terms of grams per square meter g m This quantity is commonly called grammage both in English and French ISO 536 though many English speaking countries still refer to the weight The term density here is used somewhat incorrectly as density is mass by volume More precisely it is a measure of the area density areal density or surface density Apr 2014 Version 1 All contents GS1 Page 138 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GS1 GDSN Code Group GDSN for the FDA Global Unique Device Identifier Database GUDID Code Value Description Definition Group A specialized unit of measure for the volume of rough lumber before drying and planing with no adjustments or planed surfaced lumber It netContent Dimension BF Board Foot is tho voluma of a one foot length of a board
103. S1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress A kilogram force per square centimeter kgf cm2 often just kilogram per square centimeter kg cm2 or kilopond per square et Kilogram per centimeter is a unit of ureMinimum UoM i 3 4 transportationEnvironmentAtmospheri Pressure D5 square pressure using metric units Its cPressureMaximum UoM and centimetre use is ee A transportationEnvironmentAtmospheri e part o T e cPressureMinimum UoM ystem o Jnits the modern metric system The unit is similar to the English unit psi Ibf in2 storageEnvironmentAtmosphericPress ureMaximum UoM 3 7 3 Pressure FP approximately equal to transportationEnvironmentAtmospheri square foot 47 88025 PASCAL s cPressureMaximum UoM and i transportationEnvironmentAtmospheri cPressureMinimum UoM A a geaaeae The pascal symbol Pa is the storageEnvironmentAtmosphericPress SI ere wmi of Pr d ureMininim UOM stress Young s modulus an 3 Pressure PAL Pascal tensile strength It is a transportationEnvironmentAtmospheri cPressureMaximum UoM and transportationEnvironmentAtmospheri cPressureMinimum UoM measure of force per unit area defined as one newton per square metre Apr 2014 Version 1 All content
104. SizeValue height width depth a A kilometre is one thousand km Kilometer and netContent Pilon Kun J33 1000 metres clinicalSizeValue height width depth Tie mete t tro leste Wri i m Meter Bnd acta ey Dimension MTR J34 length in the International System of Units SI clinicalSizeValue height width depth A A millimetre is one thousandth mm Millimeter and netContent Dimension siei ME of a metre 0 001 Apr 2014 Version 1 All contents GS1 Page 118 of 256 1 GS GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Code GS1 GDSN Attribute Code Code Value GS1 GDSN Attribute Description Definition Group Code Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm Nanometer clinicalSizeValue C45 20 has this as Pore Size code C45 A Change Request has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 20 has this as Pore Size code C52 A Change Request has been submitted to correct UoM Length Size ae Pie pene Nee A micrometre is one millionth Units of Measure um Micrometer aoe or Hoe width depth Dimension 4H J35 of a metre also termed Pore Size SUCpece en Micron Psia pound force per square inch absolute is a unit of pressure relative to a vacuum such as that
105. Specification should determine whether there are any patents that may encompass a specific implementation that the organization is developing in compliance with the Specification and whether a license under a patent or other intellectual property right is needed Such a determination of a need for licensing should be made in view of the details of the specific system designed by the organization 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 document nor does it make a commitment to update the information contained herein May 2014 Version 1 1 All contents GS1 Page 3 of 256 Document Summary Document Item Current Value Document Title GDSN Guide for the FDA GUDID Implementation Guide GDSN for the FDA Global Unique Device Identi
106. TIONAL Indicates that a healthcare trade item is safe to use under specified conditions in a Magnetic Resonance Imaging MRI System MRI Safety Status MR Safe mRICompatibility MRI_SAFE Indicates that the healthcare trade item is safe to use within a Magnetic Resonance Imaging MRI system MRI Safety Status MR Unsafe MRICompatibility MRI_UNSAFE Indicates that a healthcare trade item is not safe to use in an MRI system MRI Safety Status Labeling does not MRICompaitibility UNSPECIFIED The manufacturer of the Trade Item has not communicated information on the compatibility of this trade item with a Magnetic Resonance Imaging MRI System Over the Counter OTC Over the Counter Consumer Sales OTC Over the Counter products that may OTC Conditions be sold without a prescription These products are generally available without restrictions Packaging Type GDSN utilizes the Packaging Type Code AAA Pallet Returnable Pallet Returnable code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AAB Splash Blend Splash Blend Splash blending is the code value however mixing of two gasoline products of GUDID currently different octane levels in a tank on needs a term for the the delivery vehicle to produce a code The term in third blended grade of motor fuel for the description field resale at right should be pass
107. Temperature Tempat OEL pege Gelir boiling point 100 C at Atmospheric UoM and standard atmospheric Pressure D ee eee pressure placing the boiling o and freezing points of water exactly 100 degrees apart Apr 2014 Version 1 All contents GS1 Page 122 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute ee CDSN cee Description Definition Crou Code Group Value p storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingTemperatureMinimum temperature equal to 1 273 16 UoM of the absolute temperature of transportationMaximumTemperature Temperature KEL Kein the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM Currently no GDSN Value for FDA GUDID UoM UN Recommendation 20 has this as code KPA A Change Request has been submitted to correct storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum f z UoM transportationHumidityMaximum Proportion P1 Percent A miio a equal to UoM and ia transportationHumidityMinimum UoM storageHandlingTemperatureMaximu neim anenneit kampen ature m UoM a e point of ae water is egrees storageHandlingT emperatureMinimum Fahrenheit pe bolling TOM T t FAH Pegres int 212 F at standard transportationMaximumTemperature
108. Text 1 70 characters Multiple Occurrence GDSN Required OPTIONAL however if any of the three is provided an instance of all three are required Population Guidance below The GDSN attribute contactType signifies which type of contact information is being povided For ond use of consumer support the ode velo hous be Apr 2014 Version 1 All contents GS1 Page 196 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID The GDSN attributes communicationChannelCode and communicationNumber can repeat as a pair of attributes for a single contactT ype 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 EMAIL the corresponding communicationNumber will map to the GUDID attribute Supper Customer Contact Email Where an instance of the GDSN attribute communicationChannelCode is populated with the value of EMAIL the corresponding communicationNumber will map to this GUDID attribute 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 Contact Phone and Supper Customer Contact Email Apr 2014 Version 1 All contents GS1 Page 197 of 256 GDSN for the
109. The actual Catalog Number can then be populated in the GUDID using the associated additionalPartyldentification value s The code value of SUPPLIER_ASSIGNED is defined as Definition for GDSN Major Release 3 x in 2016 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 Apr 2014 Version 1 All contents GS1 Page 169 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Apr 2014 Version 1 All contents GS1 Page 170 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 11 Device Description max 2000 characters FDA GUDID Description Additional relevant information about the device that is not already captured as a distinct GUDID data attribute Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public
110. The international foot is Units E ft_i Feet eee anes Paan a depth Dimension FOT Foot defined to be a to 0 3048 Lengt meters UoM Length Size we T i An international inch is Units of Measure in_i Inch AE pee ae depth Dimension INH Inches defined to be equal to 25 4 Length millimeters UoM Length Size TR Tee T y ee 5 clinicalSizeValue height width depth A yard is It is equal to 3 feet or Units of Measure yd_i Yard and netContent Dimension YRD Yard ag inches or 0 0144 meter Length UoM Length Size rae een ae rere 3 gt clinicalSizeValue height width depth A A centimetre is equal to one Units of Measure cm Centimeter Le Saree p Dimension CMT Centimetre Maen ora neire Length UoM Length Size a Tere ewe 7 s x clinicalSizeValue height width depth F F A decimetre is equal to one E dm Decimeter ang TAN p Dimension DMT Decimetre tenth ofa metra Apr 2014 Version 1 All contents GS1 Page 113 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure fm Femtometer clinicalSizeValue A71 20 has this as Length code A71 A Change Request has been submitted
111. Value height width depth Dimension DMT Decimerre A decimetre is equal to one tenth of a metre A kilometre is one thousand and netContent km Kilometer and netContent Pilon Kun CEILS 1000 metres na TO The metre is the basic unit of m Meter Gene rae voi depth Dimension MTR Metre length in the International ananem onien System of Units SI mm Millimeter clinicalSizeValue height width depth Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Apr 2014 Version 1 All contents GS1 Page 112 of 256 FDA GUDID Code GDSN for the FDA Global Unique Device Identifier Database GUDID Attribute Code Code Value GS1 GDSN Attribute ea rae Description Definition Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm Nanometer clinicalSizeValue C45 oe 7 Height code C45 Change Request has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 ae i Height code C52 Change Request has been submitted to correct UoM Length Size ee f Reece A micrometre is one millionth Units of Measure um Micrometer A irs Poems depth Dimension 4H Micrometre ofa oe also termed Height icron UoM Length Size oy 7 EON
112. a Qualities can ieee Aid eae ie dada titeidedin ideas 127 1 7 Data Management sii eee ecient denen eves donee as EE vee ce ee cge eee 127 1 8 Data GOVEIMan CG iss sivcies ccisvecncivevessdvvevestdedevescusdevseadevevse E A 149 1 9 Roles and Responsibilities 2 2 2 0 ceeccceceesceceeeeeecceeeeseeeeeesaneeeesaeeesesaeeesessaneesessaneeseneanes 149 GDSN Datel POW wcccsicticeccicesucacesenndcctecnedccesenaderbucwassteaieasantunvaderenswtdoriocredcceasviderdassadcteeds 1610 GUDID Data Requirements cuicicccieicoscsntassscscenecsassensensersanseuscstsnsansensensensasienecsastsanseasens 1844 GDSN to GUDID Mapping sae esterase ae ee caer eat eerie ete 5338 Guidance On Populating Value wiisiccccccvocescsccsecrccecccecsdcxcecssecesevecenseersearecaverereecxeecss 157472 PICTON GIN COS sicissesietcsnatanccssnstamintsndaccxaseidenssnducaucesinanndaatincnsaueitansaueyimmsiaeuceitaneuecreaenintas 256242 May 2014 Version 1 1 All contents GS1 Page 8 of 256 Draft pending IP Review and Ratification 1 1 1 2 1 3 1 3 1 1 3 2 GDSN for the FDA Global Unique Device Identifier Database GUDID Introduction Purpose of this Document The purpose of this document is to explain how to use the Global Data Synchronization Network GDSN 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 sin
113. actual Product Code can then be populated using the associated value in the GDSN attribute additionalClassificationCategoryCode Apr 2014 Version 1 All contents GS1 Page 211 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID This set of attributes will also be used to populate several pieces of information FDA Product Code FDA Premarket Submission Number EN a aee Se and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device Apr 2014 Version 1 All contents GS1 Page 212 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 nod ate auopnlatd Tes whose maton Auto Populated NA NA NO Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the Product Code submitted Apr 2014 Version 1 All contents GS1 Page 213 of 256 36 FDA Listing Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Tr
114. alue however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PIR Pirns Pirns Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PKG Package Package Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PLC Primary Lift Container Primary Lift Container The largest outermost unitized package or articles secured together that can be handled usually mechanically in common shop floor warehouse applications as a single entity primary indicates preferred or mandatory Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code PLF Platform Platform Apr 2014 Version 1 All contents GS1 Page 94 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description where Definition applicable FDA GUDID Code Attribute Cis IC Bio N KO 5 Code Value Walle GS1 GDSN Attribute Code Group at right should be passed to th
115. alues LOV New DI Trigger Public Private Status Indicates 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 purchase in the marketplace Commercial Distribution Status Indicates whether the device is in commercial distribution as defined under 21 CFR 807 3 b NO Public NO Public Alternative or Additional Identifiers Direct Marking DM Device Subject to Direct Marking DM but Exempt The device is exempt from Direct Marking requirements under 21 CFR 801 45 NO Public May 2014 Version 1 1 All contents GS1 Page 26 of 256 Data Element Description GDSN for the FDA Global Unique Device Identifier Database GUDID DM DI Different from Primary DI Indicates that the DM DI Number is different than the Primary DI Number if appropriate DM DI Number 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 LL ih pyar Public Data Type amp Entry List of New DI Required i o Private Length Values LOV Trigger Stat
116. an Case Can Case Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CG Card Card A flat package to which the product is hung or attached for display Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code CHE Cheeses Cheeses Apr 2014 Version 1 All contents GS1 Page 80 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute GS1 GDSN Code Val Code Value Vaie GS1 GDSN Attribute where Definition applicable Code Group at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CHS Chest Chest Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CLD Car Load Rail Car Load Rail Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the
117. and a value High value for GUDID Code for Storage Type Storage environment temperature storageHandling TemperatureMinimum UoM Numeric Code List The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value Low value for GUDID Code for Storage Type Storage environment temperature transportationEnvironmentAtmospheric PressureMaximum UoM Numeric Code List 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 transportationEnvironmentAtmospheric PressureMinimum UoM Numeric Code List The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected AVP transportationEnvironmentAtmosphericP ressureMaximum AVP transportationEnvironmentAtmosphericP ressureMinimum GUDID Code for Storage Type Handling Environment Atmospheric Pressure transportationEnvironmentAtmospheric PressureMaximum UoM Numeric Code List 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 AVP transportationEnvironmentAtmosphericP ressureMaximum High Value for GUDID Code for St
118. aredReusability Type Code List 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 LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of a value of SINGLE_USE in manufacturerDeclaredReusabilityType all other values equate to a FALSE value Production Identifier s on Label Lot or Batch Number 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 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 Apr 2014 Version 1 All contents GS1 Page 62 of 256 FDA GUDID Data Element Manufacturing Date GS1 GDSN Attribute Name isPackageMarkedWithManufactureDate GDSN Data Type Boolean GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition Is the package marked with the date upon which the trade
119. assification schema FDA Product Code additionalClassificationCategoryAgency Code List additionalClassificationCategoryCode Text 1 15 characters Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Use code 43 Code value managed by FDA FDA will populate based on the FDA Product Code FDA Listing additionalTradeltemldentificationType Code List Type of the identification system that is being used as an alternative to the Global Trade Item Number Apr 2014 Version 1 All contents GS1 Page 60 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Notes Alternative means to the additionalTradeltemldentificationValue Code List Global Trade Item Number to identify a trade item FDA GUDID Data Element GS1 GDSN Attribute Name CDNA EDE ICEY 0 GDSN Definition Section 510 k of the Food Drug and Cosmetic Act requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance This is known as Premarket Notification also called PMN or 510 k This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories Specifically medical device manufacturers are required to submit
120. ata Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Es c D en Q O Z e GS1 GDSN Attribute Name LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of any value in initialSterilisationPriorToUse Definition N A Data Type N A GDSN Required OPTIONAL Population Guidance below The GDSN attribute initialSterilirilizationPriorToUse is a code list indicating the type s of sterilization which should be performed on a device prior to use Population of a value for this attribute signifies that the device is not 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 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 can not be changed Many of the data elements are locked and can no longer be edited Apr 2014 Version 1 All contents GS1 Page 253 of 256 63 Sterilization Method FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population G
121. atural rubber heme re me or ary as described under natural rubber Required DBS 21 CFR Cena 801 437 indicates that the one of the following May 2014 Version 1 1 All contents GS1 Page 42 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID ney Public AA Te aoe Data Entry Ao Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger e Device labeled NO Public as Not made with natural rubber latex RE ae May 2014 Version 1 1 All contents GS1 Page 43 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Prescription Status Prescription Indicates that the Use Rx device requires a prescription to use NO Public Over the Indicates that the NO Public Counter OTC device does not require a prescription to use and can be purchased over the counter OTC LL kLL k MRI Safety Status May 2014 Version 1 1 All contents GS1 Page 44 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID pe Public AA Te a Data Entry Aa Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger Ep 04 Boolean l NO Public NO Public py i
122. ay 2014 Version 1 1 All contents GS1 Page 32 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Device Status Human Cell Tissue or Cellular or Tissue Based Product HCT P 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 pee ee al A L NO Public May 2014 Version 1 1 All contents GS1 Page 33 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Kit Indicates that the device isa convenience combination in vitro diagnostic IVD or medical procedure kit Kits are a collection of products Type NA including medical Boolean devices that are packaged together to achieve a common intended use and is being distributed as a medical device Combination Indicates that the Product product is comprised of two or more regulated products that are physically chemically or otherwise combined or mixed and produced as a single entity packaged YES Public YES Public May 2014 Version 1 1 All contents GS1 Page 34 of 256 together as a single package or packaged separately for the intended use together as defined under 21 CFR 3 2 e At least one of the produ
123. be passed to the FDA GUDID Packaging Type Code SLV Sleeve 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 Packaging Type GDSN utilizes the code value however GUDID currently Packaging Type Code SPI Spin Cylinders Spin Cylinders Apr 2014 Version 1 All contents GS1 Page 98 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute GS1 GDSN Code Code Group Code Value GS1 GDSN Attribute Value where Definition applicable needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code SPL Spool Spool code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code SPR Separator Divider Separator Divider In packaging any code value however material inserted between tiers or GUDID currently layers of articles to prevent contact needs a term for the and provide protection code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code SRW Shrink Wrap Shrink Wrap In packaging a plastic
124. bjected d The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected e f The maximum humidity in percentages in which the trade items should be transported The minimum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below The GDSN attributes are pairs of attributes with a minimum and a maximum value This provides a range of applicability for the device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name 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 The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes GUDID Storage Type Code GDSN Attributes Storage environment temperature storageHandlingTemperatureMinimum storageHandlingTemperatureMaximum Storage environment humidity storageHandlingHumidityMinimum storageHandlingHumidityMaximum Apr 2014 Version 1 All contents GS1 Page 242 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Storage environment atmospheric pr
125. blic devices in the base of devices Example Length 7 Base Package Device Count 100 May 2014 Version 1 1 All contents GS1 Page 20 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Unit of Use DI An identifier Public Number 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 Labeler DUNS Number Required NO Private Mra May 2014 Version 1 1 All contents GS1 Page 21 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID May 2014 Version 1 1 All contents GS1 Page 22 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 3 Public AA Te aoe Data Entry Aa Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger las Nanterre in changed directly most are auto conpanrtane populated feds Popufated NA NA Pan the device label Ta Company Company physical Auto populated NA data N A Private Address DUNS Number Number Ideally this an Peo another data ceoevaaens Mammen requirement for Brand Name The eee YES Public Proprietary T
126. butes using this group of attributes are Kit and Combination Products Apr 2014 Version 1 All contents GS1 Page 199 of 256 GDSN for the FDA Global Unique Device Identifier Database 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 not be changed Many of the data elements are locked and can no longer be edited Apr 2014 Version 1 All contents GS1 Page 200 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 30 Combination Product FDA GUDID Description Indicates that the product is comprised of two or more regulated products 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 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 Data Entry Notes Webtool Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Temporary population until final GDSN deployment groupedProduct value populated in GDSN is COMBINATION 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 lt ES V Cc J Data
127. c Resonance Imaging MRI system Clinically Relevant Size clinicalSizeType Code List 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 AVP clinicalSizeType Numeric Code List a needle or 200 cc for a 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 AVP clinicalSizeValue and clinicalSizeValueUoM syringe Carries a UoM from the Recommendation 20 code list clinicalSizeText Text 1 to 200 characters When the clinicalSizeType is coded as other 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 AVP clinicalSizeText Storage and Handling Apr 2014 Version 1 All contents GS1 Page 64 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name storageEnvironmentAtmosphericPressu reMaximum UoM GDSN Data Type Numeric Code List GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected storageEnviro
128. cates there are 5 packs in the case 3061414111111 10 0061414111111 Indicates there are 10 eaches in the pack 4061414111111 2 3061414111111 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 Apr 2014 Version 1 All contents GS1 Page 188 of 256 22 Contains DI Package FDA GUDID GS1 Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Choose a value from the drop down LOV Webtool Wi Z cs O ChildTradeltem globalTradeltemNumber A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Identifier 14 digits DEPENDENT 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 Contains DI Package
129. ce 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 manufacturers 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 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 manufacturer should consider prior to using the GDSN to reg
130. code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CYL Cylinder Cylinder A rigid cylindrical container with straight sides and circular ends of equal size Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DBK Dry Bulk Dry Bulk Apr 2014 Version 1 All contents GS1 Page 84 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID Cis IC Bho KO Value Code Description where applicable Double length Rack Definition Double length Rack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DRM Drum Drum Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging T
131. comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates LOGICAL POPULATION Logical transmissible agents such as BOOLEAN value of TRUE from the fungi bacteria viruses prions population of any value in and spore forms etc from a initialManufacturerSterilisation surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene initialManufacturerSterilisation Code List LOGICAL POPULATION Logical Data Pool to default on outbound BOOLEAN value of TRUE from the message population of any value in initialSterilisationPriorToUse 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 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 initialSterilisationPriorToUse Code List Apr 2014 Version 1 All contents GS1 Page 69 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 5 FDA GUDID mapping to GS1 code values The list below are FDA GUDID code values map
132. costs improve productivity and accelerate speed to market 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 manufacturer Please refer to the specific regulation for more information Data Management Data Management 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 manufacturer 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 t
133. ctly 7 000 grains per avoirdupois pound grossWeight and netContent Mass GT Gross Kilogram A unit of mass defining the total number of kilograms before deductions grossWeight and netContent Mass HGM Hectogram A hectogram is one hundred 100 grams Apr 2014 Version 1 All contents GS1 Page 142 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Group A unit of mass equal to one grossWeight and netContent Mass KG Kilogram thousand grams The international avoirdupois grossWeight and netContent Mass LB Pound pound of exactly 0 45359237 kilogram te Ton UK or long Ton UK 1016 Kg or 2240 grossWeight and netContent Mass LTN ton US Lb SN ne A milligram is one thousandth grossWeight and netContent Mass ME Milligram of a gram 0 001 Million A unit of count defining the grossWeight and netContent Mass MIU International Unit number of international units NIE in multiples of 106 grossWeight and netContent Mass MP Metric Ton ae One billionth grossWeight and netContent Mass NGM Nanogram 1 4 000 000 000 of a gram The weight of one square yard of the material expressed in ounces Commonly used to
134. cts in the combination product must be a device in this case GDSN for the FDA Global Unique Device Identifier Database GUDID Premarket Device Exempt Device is exempt from Premarket from FDA Submission Premarket regulations or a preamendment NO Public May 2014 Version 1 1 All contents GS1 Page 35 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID FDA Premarket Number Public Submission associated with Number 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 May 2014 Version 1 1 All contents GS1 Page 36 of 256 Supplement Number GDSN for the FDA Global Unique Device Identifier Database GUDID Public May 2014 Version 1 1 All contents GS1 Page 37 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Pps Public AA Te nora Data Entry Ao Data Type amp Entry List of New DI r Data Element Description Notes reas Required Length Values LOV Trigger oe FDA Product Code Product Code aoa il NO Public Eee of entered data gating emanate Len deve Edit Editing of a ee Product Code Name ai
135. d of a netContent Sound 2N Decibel mosquito flying 3 metres away This is often abbreviated to just dB however the correct abbreviation is dB SPL indicating decibel for Sound Pressure Level Apr 2014 Version 1 All contents GS1 Page 147 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute storageHandlingTemperatureMaximu GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Celsius also historically known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM F degrees Celsius C and the transportationMaximumTemperature Temperature Of Degrees Celsius boiling point 100 C at UoM and standard atmospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart storageHandlingTemperatureMaximu Tie Palrenhei lemipelallle faa as USN scale the freezing point of storageHandlingTemperatureMinimum KENET IB SE CETEES Fahrenheit F and the boiling trans ert nen erature Temperature FA a point 212 F at standard p UoM and p atmospheric pressure PR placing the boiling and ae uae ees a freezing points of water exactly 180 degrees apart netContent Time ANN Year
136. dentifier Database GUDID FDA GUDID Code Attribute Code Code Value ERIR CIDIN Code GS1 GDSN Attribute Description Definition Code Group Value Group grouped in a mixed collection A unit of measure for blood potency International units for Anti XA Unit the anti XA activity which is a netContent Count AXU International measure to the anti Units coagulating effect at low molecular heparins A unit of measure for blood potency The becquerel symbol Bq is the SI derived unit of radioactivity One Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second SI uses the becquerel rather than the netContent Count BQL Becquerel second for the unit of activity measure to avoid dangerous mistakes a measurement in becquerels is proportional to activity and thus a more dangerous source of radiation gives a higher reading A measurement in seconds is inversely proportional A unit of count defining the netContent Count CG Card number of units of card card thick stiff paper or cardboard CH Centesimal Scale Attenuation One millilitre 1 0 ml of the first centesimal liquid attenuation 1C or one gram 1 0 g of the first centesimal trituration 1C represents 0 01 gram 10 0 mg of the dry crude medicinal Centisimal substance Subsequent liquid netContent Count CHD Hahnemannian or solid attenuations are made Dilution CH by serial
137. e Disa a t f The international foot is ft_i Feet Sue Paa ma depth Dimension FOT Foot defined to be equal to 0 3048 Se Onie meters eee f eae Oe An international inch is lini Inch See arn a out oa a Dimension INH Inches defined to be equal to 25 4 and netConte millimeters clinicalSizeValue height width depth s A yard is It is equal to 3 feet or Iydi Yard and netContent Dimension ie Varel 36 inches or 0 9144 meter clinicalSizeValue height width depth j A centimetre is equal to one cm Centimeter and netContent Dimensie euy COMME Me hundredth of a metre dm Decimeter clinicalSizeValue height width depth Dimension DMT Decimetre A decimetre is equal to one tenth of a metre k a and netContent fm Femtometer clinicalSizeValue height width depth A kilometre is one thousand km Kilometer and netContent pension Ksi Liomete 1000 metres n a erate cr The metre is the basic unit of m Meter ee ae roa Mor casn Dimension MTR Metre length in the International ang mercone System of Units SI mm Millimeter clinicalSizeValue height width depth Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Apr 2014 Version 1 All contents GS1 Page 115 of 256 FDA GUDID Code GDSN for the FDA Global Unique Device Identifier Database GUDID
138. e Carries a UoM from the Recommendation 20 code list Data Type Measurement numeric amp UoM qualifier GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeValueUoM It will be deployed into the GDSN Schema in 2016 17 into a final 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 pools 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 can not be edited or deleted Apr 2014 Version 1 All contents GS1 Page 239 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID
139. e FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PLN Pipeline Pipeline Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PLT Pallet Pallet A platform used to hold or transport unit loads Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PO Pouch 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 Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code POV Private Vehicle Private Vehicle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PRK Pipe Rack Pipe Rack Packaging Type GDSN utilizes
140. e device labeled for MRI Safety Is no longer supported in the SP Throughout document where the SPL Information is different from the GUDID 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 Contain
141. e project problem or task The person responsible for doing the work to achieve the task e A to whom the R is Accountable who must sign off approve work before it is effective e C to be Consulted has information and or capability necessary to complete the work e to be Informed must be notified of results need not be consulted This simple yet effective model can be applied in any size company In large organizations which include divisions in various parts of the world the roles and responsibilities are usually May 2014 Version 1 1 All contents GS1 Page 14 of 256 Draft pending IP Review and Ratification GDSN for the FDA Global Unique Device Identifier Database GUDID 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 May 2014 Version 1 1 All contents GS1 Page 15 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Data Flow This section is specific to the U S FDA GUDID as it is the first UDI database This section will be updated as other regulators introduce UDI regulation Options for regi
142. e 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 OPTIONAL Data Type GDSN Required 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 initialManufacturerSterilization 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 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 can not be changed Many of the data elements are locked and can no longer be edited Apr 2014 Version 1 All contents GS1 Page 252 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 62 Requires Sterilization Prior to Use FDA GUDID Description Indicates that the device requires sterilization prior to use Data Entry Notes Edit Rules After Grace Period Required D
143. e s molecular or atomic weight in grams That is to say a substance s atomic or molecular mass in atomic mass units is the same as its molar mass in grams Because of this one can measure the number of moles in a pure substance by weighing it and comparing the result to its molecular or atomic weight grossWeight and netContent Mass CGM Centigram A centigram is one hundredth 1 100 of a gram grossWeight and netContent Mass CW Hundred Pounds CWT grossWeight and netContent Mass CWA Hundred pound cwt hundred weight US A unit of weight in the U S Customary System equal to 100 pounds 45 36 kilograms also called cental grossWeight and netContent Mass CWI Hundred weight UK A unit of weight in the British Imperial System equal to 112 pounds 50 80 kilograms also called quintal grossWeight and netContent Mass D43 Atomic Mass Units AMU Atomic Mass Units grossWeight and netContent Mass DG Decigram A decigram is one tenth 1 10 of a gram grossWeight and netContent Mass E4 Gross kilogram A unit of mass defining the total number of kilograms before deductions grossWeight and netContent Mass GR Gram One one thousandth of the kilogram 1x10 3 kg grossWeight and netContent Mass GRN Grain A grain or troy grain is precisely 64 79891 milligrams Exa
144. e 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 imila galumns in use by GDSN May 2014 Version 1 1 All co Page 5 of 256 Updated 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 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Issue No Date of Change Changed By Summary of Change 4 9 May 2014 Scott Brown 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 th
145. ed as natural rubber latex being free from fish as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_GLUTEN Marks if the product is free from natural rubber latex gluten This level of containment is frequently determined through regulation for example per EU Regulation EC No 41 2009 of 20 January 2009 this is defined as lt 20 mg kg Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_LACTOS Indicates if the amount of lactose is natural rubber latex E reduced Device labeled as Not made with TRUE packageMarksFreeFrom FREE_FROM_LATEX The item is physically marked being free from Latex rubber as approved by the appropriate authority of the Apr 2014 Version 1 All contents GS1 Page 71 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID Cis C Bio KO 5 Value Code Description where applicable Definition target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_LEGUME The item is physically marked as natural rubber latex _PROTEIN being free from legume protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_MILK The item is physically mark
146. ed as natural rubber latex being free from milk and any of its derivates as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_MILK_PR Free from milk protein natural rubber latex OTEIN Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_NATURA The item is physically marked as natural rubber latex L_GLUTEN being naturally free from gluten and not extracted as part of the manufacturing process as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PEANUT Marks if the product is free from natural rubber latex S peanuts Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PROTEI The item is physically marked as natural rubber latex N being free from protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PVC The item is physically marked as natural rubber latex being free from PVC Polyvinyl chloride as approved by the appropriate authority of the target market Device labeled as Not made with FALSE spackageMarksFreeFrom FREE_FROM_SOYA Free from soya natural rubber latex Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_SUGAR Marks if the product is free from natural rubber latex sugar Device labeled as Not made with FALSE pac
147. ed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AE Aerosol Aerosol A gas tight pressure code value however GUDID currently needs a term for the code The term in resistant container with a valve and propellant When the valve is opened propellant forces the product from the container in a fine Apr 2014 Version 1 All contents GS1 Page 74 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition the description field or coarse spray pattern or stream at right should be e g a spray can dispensing paint passed to the FDA furniture polish GUDID Packaging Type GDSN utilizes the Packaging Type Code AMM Ammo Pack Ammo Pack code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AMP Ampoule Ampoule A relatively small container code value however made from glass or plastic tubing GUDID currently the end of which is drawn into a stem needs a term for the and closed by fusion after filling code The term in The bottom may be flat convex or the description field drawn out An ampule is opened by at right should be break
148. equired N A Population Guidance below If the current date is equal to or greater than the GUDID Publication Date in GDSN then the 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 Commercial Distribution Status will be set to Not in Commercial Distribution automatically by the FDA Apr 2014 Version 1 All contents GS1 Page 176 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Select checkbox if appropriate Webtool Add Addition of new data is allowed Delete Deletion of entered data is allowed Edit Editing of entered data is allowed Conditionally Required If device is subject to 801 45 Type Boolean NA NO isTradeltemExemptFromDirectPartMarking Definition Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the target market Data Type Boolean G
149. erm for the Packaging Type Code CSK Crate Cask Apr 2014 Version 1 All contents GS1 Page 83 of 256 FDA GUDID Code Attribute Code Group Code Value code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CIN Carton Carton A non specific term for a re closable container used mostly for perishable foods e g eggs fruit Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CU Cup Cup A small bowl shaped container for beverages often with a handle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CxX2 CONEX CONEX A reusable container for shipment of cargo Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the
150. erm in the description field at right should be passed to the FDA GUDID Packaging Type Code LNR Liners Liners Any material that separates a product within a container from the basic walls of the container Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LOG Log Log Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LSE Loose Loose Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LUG Lug Lug Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code LVN Lift Van Lift Van Apr 2014 Version 1 All contents GS1 Page 91 of 256 FDA GUDID Code Attribute Code Group Code Value at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition
151. es After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Dimension type for the clinically relevant measurement of the medical device Zz O Public Temporary population until final GDSN deployment clinicalSizeType Definition Data Type GDSN Required Final Deployment Attribute Name Definition Data Type GDSN Required Population Guidance below Apr 2014 Version 1 All contents GS1 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 OPTIONAL clinicalSizeType 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 OPTIONAL Page 234 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID This attribute has a temporary attribute AVP in GDSN clinicalSizeText 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 This GUDID attribute is a Code List clarifying the qualifier type associated to the c
152. escription where applicable Definition Current definition 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 the goods and consigns or makes them available in trade Definition for GDSN Major Release 3 x in 2016 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 natural rubber latex Contact Used to provide Contact Type CONSUMER_SUPPOR The party which provides product Contact Information T support to the end user of a trade for GUDID item or a service Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_EGG Marks if the product is free from egg natural rubber latex Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_FISH The item is physically mark
153. escription field at right should be passed to the FDA GUDID Packaging Type Code CND Container Commercial Highway Lift Container Commercial Highway Lift Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNE Container Engine Container Engine Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNF Container Multi walled Secured to Warehouse Pallet Container Multi walled Secured to Warehouse Pallet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNT Container Container Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code COL Coil Coil Apr 2014 Version 1 All contents GS1 Page 82 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for
154. essure storageEnvironmentAtmosphericPressureMaximum storageEnvironmentAtmosphericPressureMinimum AVP Handling environment temperature transportationMaximumT emperature transportationMinimumTemperature Handling environment humidity transportationMaximumHumidityMaximum transportationMaximumHumidityMinimum AVP Handling environment atmospheric pressure transportationEnvironmentAtmosphericPressMaximum transportationEnvironmentAtmosphericPressMinimum AVP 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 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 fields Maximum or High Values Field All contents GS1 Page 243 of 256 Apr 2014 Version 1 GDSN for the FDA Global Unique Device Identifier Database GUDI
155. evere applications Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code ROL Roll Roll Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code RVR Reverse Reel Reverse Reel Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SAK Sack Sack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SCS Suitcase Suitcase Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code SHK Shook Shook Apr 2014 Version 1 All contents GS1 Page 97 of 256 FDA GUDID Code Attribute Code Group Code Value at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value
156. f 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 Apr 2014 Version 1 All contents GS1 Page 204 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 32 FDA Premarket Submission Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN 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 2 Ze 5 Pair of attributes in combination a additionalClassificationAgencyName Code 58 for b additionalClassificationCategoryCode Apr 2014 Version 1 All contents GS1 Page 205 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Definition a Text name of the additional external cla
157. f attributes will be provided as additionalPartyldentificationType Code List a code other than the Global additional party identification for the Location Number Brand Owner GLN Apr 2014 Version 1 All contents GS1 Page 54 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name additionalPartyldentificationValue brandName additionalTradeltemldentificationType GDSN Data Type Text 1 to 35 characters GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition A party identifier that is in addition to the GLN The recognisable name used by a brand owner to uniquely identify a line of trade item or services This is recognizable by the consumer GDSN Notes Code List Type of the identification system that is being used as an alternative to the Global Trade Item Number Use code value of MODEL_NUMBER additionalTradeltemldentificationValue Text Alternative means to the Global Trade Item Number to identify a trade item additionalTradeltemldentificationType Code List Type of the identification system that is being used as an alternative to the Global Trade Item Number Use code value of SUPPLIER_ASSIGNED additionalTradeltemldentificationValue additionalTradeltemDescription Text Alternative means to the Global Trade Item Number to identify a trade item Text 1 to 350 characters Additional variants
158. f the absolute temperature of transportationMaximumTemperature Temperature KEL Kein the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM Page 125 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID CRIER Code Group Description Definition storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum E UoM transportationHumidityMaximum Proportion P1 Percent A umiai aer eguel te UoM and seta transportationHumidityMinimum UoM f The Fahrenheit temperature R oy ae age scale the freezing point of 2 RE water is egrees storage hanana emperar Mnimum Fahrenheit F and the boiling UN Temperature FAH Degree int 212 F at standard transportationMaximumTemperature p Fahrenheit po A at standar oM and atmospheric pressure transportationMini 3 T t placing the boiling and portationMinimumTemperature ffeesin EE UoM g points of wate exactly 180 degrees apart Celsius also historically storageHandlingTemperatureMaximu known as centigrade is a m UoM temperature scale the storageHandlingTemperatureMinimum freezing point of water is 0 UoM degrees Celsius C and the transportationMaximumTemperature Temperature Degree Celsius boiling point 100 C at UoM and standard atm
159. field at right should be passed to the FDA GUDID Packaging Type Code RCK 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 baker Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code REL Reel 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 Apr 2014 Version 1 All contents GS1 Page 96 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Reinforcement Definition Reinforcement In containers and shipping devices a component usually temporary added to a container for a particular application to lend additional support under s
160. fier Database GUDID Date Last Modified 9 May 2014 Current Document Issue Issue 1 1 Status Pending Ratification and IP Review 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 Organization Pete Alvarez GS1 Global Office Scott Brown GS1 US Change Log Issue No Date of Change Changed By Summary of Change 1 9 September 2013 Pete Alvarez Merger of sections created by Pete Alvarez Global Office and Scott Brown GS1 U S 2 6 January 2014 Scott Brown Updated section GDSN to GUDID Attribute Mapping and Guidance on Populating Attributes per latest FDA GUDID requirements and User Guide 3 8 January 2014 Final Review prior to submitting into the GSMP May 2014 Version 1 1 All contents GS1 Page 4 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Issue No Date of Change Changed By Summary of Change 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
161. following 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 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 fDAGUDIDPublishDate AVP and a final trading partner dependent deployment of uDIDPublishDate 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_COMPATIBLE Corrected missing words in the FDA Required column foe S
162. g for population in the GUDID Quantity per Package DI Number 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 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 Apr 2014 Version 1 All contents GS1 Page 190 of 256 23 Package Type FDA GUDID GS1 Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations 2 D packagingTypeCode The code identifying the type of package used as a container of the trade item Text 1 3 characters Optional 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 packagin
163. g 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 asking for a descriptive term 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 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 Apr 2014 Version 1 All contents GS1 Page 191 of 256 24 Package Discontinue Date FDA GUDID GS1 Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates the date this particular package configuration is discontinued by the Labeler Wh Public discontinuedDate Communicate the date on which the trade item is no longer to be manufactured Allows the reuse of the GTIN after 48 months with the explicit exception of Apparel being 30 months and the implicit exception for specialty products e g steel beams Date Time CCYY MM DDTHH MM SS Optional This attribute is populated from the globalTradeltemNumber which is being used to p
164. h may or may not have a cover used for displaying or carrying items Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TSS Trunk Salesmen Sample Trunk Salesmen Sample Packaging Type GDSN utilizes the code value however GUDID currently Packaging Type Code TUB Tub Tub Generally a round flat bottomed container closed with a large lid typically used to contain ice Apr 2014 Version 1 All contents GS1 Page 101 of 256 FDA GUDID Code Attribute Code Group Code Value needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition cream margarine sour cream confections and other products Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code UNP Unpacked Unpacked The item is provided without packaging Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the descrip
165. he Global Harmonization Task Force plus additional information required by the U S FDA In this step the manufacturer 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 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 May 2014 Version 1 1 All contents GS1 Page 12 of 256 Draft pending IP Review and Ratification GDSN for the FDA Global Unique Device Identifier Database GUDID quality guidance and best practices based on industry experience including the GS1 Data Quality Protocol Below are a few basic steps to consider e Completeness Is data missing which is needed for that specific product e Accuracy Is data precise correct and current e Conformity Have formatting rules and standards been applied properly e Logic Is data valid or conflicting across product classes e Consistency Is data consistent across systems for the same field e Integrity Are
166. height width depth A centimetre is equal to one Units of Measure cm Centimeter Le ere p Dimension CMT Centimetre Maen ora neire Depth UoM Length Size ee T ae 7 7 z clinicalSizeValue height width depth F F A decimetre is equal to one Units O dm Decimeter and netContent Dimension DMT Decimetre tenth of a metra Apr 2014 Version 1 All contents GS1 Page 110 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition Group Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure fm Femtometer clinicalSizeValue A71 20 has this as Depth code A71 A Change Request has been submitted to correct UoM Length Size oe 3 i clinicalSizeValue height width depth A A kilometre is one thousand Units a km Kilometer DWC Dimension KMT Kilometre 1000 metres abe m Meter eal a eee depth pidencion MTR Metre ae Peete Depth System of Units SI UoM Length Size eon s ae E Tih 5 Unico Meastiie lt mm Millimeter ClinicalSizeValue height width depth Dimension MMT Millimetre A millimetre is one thousandth and netContent of a metre 0 001 Depth Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm
167. ht Currently it is both a small mass in the Apothecaries system of weights and a small unit of volume This unit is called more correctly fluid dram or in contraction also fluidram The term also refers to the fluid dram a measure of capacity equal 18 of a fluid ounce which means it is exactly equal to 3 696 691 195 3125 mL in the United States Apr 2014 Version 1 All contents GS1 Page 150 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute netContent Code Group GS1 GDSN Volume GDSN for the FDA Global Unique Device Identifier Database GUDID Code Value DRI Description Dram Uk Definition The dram archaic spelling drachm was historically both a coin and a weight Currently it is both a small mass in the Apothecaries system of weights and a small unit of volume This unit is called more correctly fluid dram or in contraction also fluidram The fluid dram is defined as 14 of a fluid ounce which means it is exactly equal to 3 551 632 812 500 0 mL in the Commonwealth and Ireland In England dram came to mean a small draught of cordial or alcohol hence the term dram house for the taverns where one could purchase a dram netContent Volume FO Fluid Ounce netContent Volume FTQ Cubic foot A cubic foot is the volume of a cube of side length one foot 0 3048 m netContent Volume G23 Peck
168. ibute Name Pair of attributes in combination a additionalPartyldentification type b additionalPartyldentification value Definition a Identification of a party by use of a code other than the Global Location Number b A party identifier that is in addition to the GLN Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair of attributes is populated both attributes must be populated 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 Apr 2014 Version 1 All contents GS1 Page 162 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Population of this value can be accomplished by populating the code values DUNS or DUNS_PLUS_ FOUR in the GDSN attribute Additional Party Identification type tied to the attribute Brand Owner GLN The actual DUNS or DUNS _ PLUS FOUR number can then populated in the GDSN attribute Additional Party Identification value The number populated in Additional Party Identification value will be populated in GUDID as the Labeler DUNS Number Apr 2014 Version 1 All contents GS1 Page 163 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 6 Company Name FDA GUDID Description Data Entry Notes Edit Rules After
169. ibute combination of additionalTradeltemldentificaton type of DIRECT_PART_MARkK and an associated additionalTradeltemldentificaton value then the logical value for the GUDID is TRUE else this value is FALSE Apr 2014 Version 1 All contents GS1 Page 178 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment directPartMarking Definition This is a number or marking placed directly on the medical device Data Type Text GDSN Required Optional Final Deployment Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence Apr 2014 Version 1 All contents GS1 Page 179 of 256 GDSN for the FDA Global Unique Device Identifier
170. icates storage and handling requirements that are required for the device including temperature humidity and atmospheric pressure Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV dit N O Public Private Status Public GS1 GDSN Attribute Name LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Name New DI Trigger a storageHandlingTemperatureMaximum b storageHandlingHumidityMaximum c transportationMaximumTemperature Definition a The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value b The maximum humidity in percentages that the goods should be stored in c The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironmentAtmosphericPressureMaximum Apr 2014 Version 1 All contents GS1 Page 247 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID b transportationEnvironmentAtmosphericPressMaximum c transportationMaximumHumidityMaximum Definition a The maximum atmospheric pressure in which the item should be stored to remain usable This value is the
171. icationNumber can repeat as a pair of attributes for a single contactT ype 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 communicationNumber will map to the GUDID attribute Supper 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 Contact Phone and Supper Customer Contact Email Apr 2014 Version 1 All contents GS1 Page 195 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 27 Support Customer Contact Email FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a contactType b communicationChannelCode c communicationNumber Definition a The general category of the contact party for a trade item for example Purchasing b Means used to communicate with another party c Number assigned to a specific means of communication Data Type a Code List b Code List Multiple Occurrence c
172. igger Public Private Status GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID 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 2 D Temporary population until final GDSN deployment fDAMedicalDeviceListing Definition Data Type GDSN Required Most Owners or operators of places of business also called establishments or 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 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 Text Optional Final Deployment Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type Code of FDA_MEDICAL_DEVICE_LISTING b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type Apr 2014 Version 1 All contents
173. ing if this element will be posted on the FDA GUDID public facing website PUBLIC or for FDA consumption only PRIVATE May 2014 Version 1 1 All contents GS1 Page 18 of 256 Draft pending IP Review and Ratification 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Document reference e The FDA term GS1 14 digit numeric value is equal to a GTIN e The FDA term Primary DI in GS speak would be the primary device GTIN For example a DI 101 is the Primary GTIN and Dis 201 and 301 would be the packaging levels May 2014 Version 1 1 All contents GS1 Page 19 of 256 Draft pending IP Review and Ratification GDSN for the FDA Global Unique Device Identifier Database GUDID eae Public SIPA Data Entry TAC Data Type amp Entry List of New DI 7 Data Element Description Notes Required Length Values LOV Trigger Private Status When a GUDID attribute appears on the medical device package label the values submitted to the GUDID should match the value on the label Device Information Device Identifier DI Information Issuing Agency Organization Choose a value Required NA GS1 HIBCC YES Public accredited by from the drop ICCBBA FDA to operate a down LOV are allowed system for the issuance of UDIs Primary DI a Required N A YES Public Number itself Device Count Numberofmedical Enterthe number Required me Nim N A YES Pu
174. ing the associated value in the GDSN attribute additionalClassificationCategoryCode Only the GMDN Gede 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 rera Mhe pieces RN and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device 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 existin Apr 2014 Version 1 All contents GS1 Page 217 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 38 Name FDA GUDID Description Name associated with the GMDN Preferred Term Code Data Entry Notes System populated based on GMDN Preferred Term Code FDA PT Code Edit Rules After Grace Period nod fe auido whose Horan Required Auto Populated Data Type amp Length NA Entry List of Values LOV NA New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name additionalClassificationCategoryDescription Definition In the additional classification system the description of the category Data Type Text 1 70 characters GDSN Required Optional Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the
175. ing the stem passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AT Atomizer Atomizer A device for reducing a code value however liquid to a fine spray g GUDID currently medicine perfume etc An needs a term for the atomizer does not rely ona code The term in pressurised container for the the description field propellant Usually air is provided by at right should be squeezing a rubber bulb attached to passed to the FDA the atomizer GUDID Packaging Type GDSN utilizes the Packaging Type Code ATH Attachment Attachment In containers and code value however shipping devices a component that GUDID currently can be added to provide additional needs a term for the functionality or security as required code The term in by the contents or method of the description field transportation handling at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BAG Bag Bag A preformed flexible container code value however generally enclosed on all but one GUDID currently side which forms an opening that needs a term for the may or may not be sealed after code The term in filling the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BAL Bale Bale code value however Apr 2014 Version 1 All contents GS1 Page 75 of 256 FDA GUDID Code Attribute Code Value Code Group GUDID cu
176. ions and leaves no residue Sterilization Method Ozone Initial Manufacture Sterilization Initial Sterilization Prior to Use OZONE Is a method often times used in industrial settings 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 Sterilization Method Peracetic Acid Initial Manufacture Sterilization Initial Sterilization Prior to Use PERACETIC_ACID A chemical in the organic peroxide family It is a bright colorless liquid with a characteristic acrid acetic acid type odor It has a strong oxidizing potential is highly corrosive and can explode at temperatures exceeding 110 C Sterilization Method Ultraviolet Light Initial Manufacture Sterilization Initial Sterilization Prior to Use Useful for sterilization 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 Sterilization Method Chlorine Dioxide Storage and Handling Type Storage Environment Atmospheric Pressure Storage and Handling GDSN Attributes StorageEnvironmentAtm osphericPressureMaxim um OR storageEnvironmentAtm osphericPressureMinimu Apr 2014 Version 1 All contents
177. ister 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 to use the GS1 system The GS1 website lists 10 basic steps to bar code 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 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 Dl 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 May 2014 Version 1 1 All contents GS1 Page 9 of 256 Draft pending IP Review and Ratificati
178. item was manufactured GDSN Notes AVP isPackageMarkedWithManufactureDate Serial Number serialNumberLocationCode Text 1 35 characters 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 number 1234569 LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of any value except NOT_MARKED in serialNumberLocationCode Indicates the type of LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of either values of BEST_BEFORE_DATE or EXPIRY_DATE in Expiration Date packagingMarkedExpirationDateType Code List expiration date marked on the packagingMarkedExpirationDate Type packaging changing to tradeltemDateOnPackagingType coming in GDSN Major Release 3 x in 2016 other values or when no value is provided would equate to a value of FALSE Indicates the device is managed by a Donation Identification Number This number can be found on the device label or packaging AVP Donation Identification Number donationldentificationNumberMarked Boolean 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 donationldentificationNumberMarked Latex Information
179. izes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA Packaging Type Packaging Type Code BIC Bing Chest Bing Chest Apr 2014 Version 1 All contents GS1 Page 76 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID Cis IC Bio KO 5 Value Code Description where Definition GUDID applicable Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BIN Bin W in Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BLK Bulk Bulk Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BLT Belting Belting As pertains to containers and shipping devices a method of securing the contents to the conveyance device or securing components of the shipping device to each other using one or more bands of flexible material ha
180. joule is 1000 joules netContent Energy KWH Kilowatt hour A kilowatt hour is a unit of energy equal to 3 6 megajoules It is also a common commercial unit of electric energy representing the amount of energy delivered at a rate of 1 000 watts over a period of one hour netContent Energy MWH Megawatt hour 1000 kW h A unit of energy defining the total amount of bulk energy transferred or consumed Apr 2014 Version 1 All contents GS1 Page 140 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition The watt hour is a unit of energy equivalent to one watt of power expended for one hour of time it is equal to 3 6 netContent Energy WHR Watt hour kilojoules The watt hour is rarely used to express energy in any form other than electrical A unit of frequency equal to netContent Frequency A86 Gigahertz 109 Hertz A unit of frequency equal to netContent Frequency D29 Terahertz 1012 Hertz A unit of frequency equal to netContent Frequency KHZ Kilohertz 103 Hertz A unit of frequency equal to netContent Frequency MHZ Megahertz 106 Hertz Candela per Square Meter is the SI base unit of luminous intensity that is power emitted
181. kageMarksFreeFrom REDUCED_LACTOSE Indicates if the amount of lactose is natural rubber latex reduced Device labeled as Not made with FALSE packageMarksFreeFrom REDUCED_PROTEIN The item is physically marked as natural rubber latex containing a low level of protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom VERY_LOW_GLUTEN The item is physically marked as a natural rubber latex very low amount of gluten Very low is frequently determined through regulation for example per EU Regulation EC No 41 2009 of 20 January 2009 this is defined as containing between 20 and 100 mg kg Device labeled as Not made with FALSE packageMarksFreeFrom WITHOUT_ADDED_SU The item is physically marked that no natural rubber latex GAR sugar has been added when manufacturing the product but it still Apr 2014 Version 1 All contents GS1 Page 72 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Definition can contain sugars that are naturally part of the ingredients as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom WITHOUT_ADDED_SW The item is physical
182. l g Gram grossWeight and netContent Mass GRM Gram thousandth of the kilogram 9 1x10 3 kg UoM Weight Units of 7 Saree A unit of mass equal to one Measure Weight kg Kilogram grossWeight and netContent Mass KGM Kilogram thousand grams UoM Weight Units of oa ARN ATE A milligram is one thousandth Measure Weight mg Milligram grossWeight and netContent Mass MGM Milligram of a gram 0 001 penr t Metric Ton grossWeight and netContent Mass TNE Tonne Metric ton 1000 Kg UoM Weight Units of Ee A microgram is one millionth Measure Weight ug Microgram grossWeight and netContent Mass MC Microgram of a gram 0 000001 A unit of area of 112 sheets of tin mil products tin plate tin netContent Area BB Base box free steel or black plate 14 by 20 inches or 31 360 square inches Apr 2014 Version 1 All contents GS1 Page 131 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Code Group Value Description Definition Group netContent Area DMK Square decimetre A square decimetre is an area of a square whose sides are exactly 1 decimetre in length netContent Area MIK Square mile A square mile is an area of a square whose sides are exactly 1 mile in length netContent Area SF Square Foot An area of a square whose sides are exactly 1 fo
183. l with a large opening which is used to store products e g jams cosmetics GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code JG Jug Jug A container normally cylindrical with a handle and or a lid or spout for holding and pouring liquids GDSN utilizes the code value however GUDID currently Packaging Type Packaging Type Code KEG Keg Keg Apr 2014 Version 1 All contents GS1 Page 89 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where Definition applicable needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code KIT Kit Kit Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code KRK Knockdown Rack Knockdown Rack Packaging Type GDSN utilizes
184. let Apr 2014 Version 1 All contents GS1 Page 154 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute netContent GDSN for the FDA Global Unique Device Identifier Database GUDID CioH MC B s Code Code Group Value PPC Description Pixels Per Centimetre Definition A unit of count defining the number of pixels per linear centimetre as a measurement of the resolution of devices in various contexts typically computer displays image scanners or digital camera image sensors netContent PPI Pixels Per Inch A unit of count defining the number of pixels per linear inch PPI as a measurement of the resolution of devices in various contexts typically computer displays image scanners or digital camera image sensors netContent PRS Potential Renal Solute Load Refers to all solutes of endogenous or dietary origin that require excretion by the kidneys Potential renal solute load PRSL refers to solutes of dietary origin that would need to be excreted in the urine if none were diverted into synthesis of new tissue and none were lost through nonrenal routes This is very important to be able to transmit for infant formulas netContent SQE SQ E Number of allergens based on the SQ E unit netContent TE Tote netContent TK Tank netContent TY Tray
185. linical 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 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 After the grace period ends on day 8 this attribute can be added but can not be edited or deleted Apr 2014 Version 1 All contents GS1 Page 235 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 53 Size Value FDA GUDID Description Numeric value for the clinically relevant size measurement of the medical device Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment N clinicalSizeValue Definition The value to denote the dimensional size which is clinically relevant for the use of
186. ll contents GS1 Page 232 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 51 MRI Safety Status What MRI safety information does the labeling contain FDA GUDID Description Data Entry Notes Webtool Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV HL New DI Trigger Public Private Status Public GS1 GDSN Attribute Name mRICompatibility Definition This is an identification of the compatibility of a trade item for use in the presence of a Magnetic Resonance Imaging MRI system Data Type Code List GDSN Required OPTIONAL 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 value While it is not recommended to use a GDSN value of UNSPECIFIED as this provides no useful information and can lead to confusion in a clinical setting However if a GDSN value of UNSPECIFIED is published this will be mapped to MR Unsafe as a default 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 Apr 2014 Version 1 All contents GS1 Page 233 of 256 52 Size Type FDA GUDID Description Data Entry Notes Edit Rul
187. ly marked that no natural rubber latex EETENER sweetener has been added when manufacturing the product as approved by the appropriate authority of the target market Device required to be labeled as FALSE Does Trade Item Contain FALSE The Brand Owner labeling does not containing natural rubber latex or Latex state the Trade Item contains latex dry natural rubber 21 CFR or may state that the Trade Item is 801 437 free from latex Device required to be labeled as TRUE Does Trade Item Contain TRUE Brand Owner labeling states the containing natural rubber latex or Latex Trade Item contains latex dry natural rubber 21 CFR 801 437 Expiration Date TRUE Packaging Marked BEST_BEFORE_DATE Not Applicable Expiration Date Type Expiration Date TRUE Packaging Marked EXPIRY_DATE Not Applicable Expiration Date Type Expiration Date Other values or no Packaging Marked value populated Expiration Date Type equates to a value of FALSE GMDN Preferred Term Code GMDN Preferred additionalClassificationAge 35 GMDN Global Medical Devices ncyName Nomenclature GMDN FDA Preferred Term Code FDA Product Code FDA Product Code additionalClassificationAge FDA Product Code US FDA Product Code Classification ncyName 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 FDA Premarke
188. n Boxes Apr 2014 Version 1 All contents GS1 Page 88 of 256 FDA GUDID Code Attribute Code Value Code Group at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID Cis C Bio KO 5 Value Code Description where applicable Definition GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code HRK Half Standard Rack Half Standard Rack GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code HTB Half Standard Tote Bin Half Standard Tote Bin GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code INT Intermediate Container Intermediate Container GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code JAR Jar Jar A rigid container made of glass stone earthenware plastic or other appropriate materia
189. nimumTemperature i Ta transportationMaximumHumidityMaximum Handling environment humidity transportationMaximumHumidityMinimum AVP Handling environment transportationEnvironmentAtmosphericPressMaximum atmospheric pressure transportationEnvironmentAtmosphericPressMinimum AVP 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 ___Populatedin_ vawe 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 Apr 2014 Version 1 All contents GS1 Page 245 of 256 Greater Than a Value GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Maximum or High Values Field Single Same Value populated in both fields Apr 2014 Version 1 All contents GS1 Page 246 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 58 High Value FDA GUDID Description Ind
190. nk wrapped or vacuum packed Apr 2014 Version 1 All contents GS1 Page 103 of 256 FDA GUDID Code Attribute Code Group Code Value at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID Cis IC Bho KO Value Code Description where applicable Definition Prescription Use Rx Prescription Use Rx Consumer Sales Conditions PRESCRIPTION_REQU IRED Trade item may only be sold or dispensed under the direction of a prescription Secondary DHssuing Agency ICCBA Secondary DHssuing Agency GS1 Additional Trade Item Not needed as there can only be one Identification Type GTIN for an item and therefore cannot be a secondary GTIN Serial Number TRUE serialNumberLocationCode MARKED_ON_PACKA Serial number is on the trade item s GING packaging Serial Number TRUE serialNumberLocationCode MARKED_ON_PACKA Serial number is on the trade item s GING_INSERT packaging insert Serial Number TRUE serialNumberLocationCode MARKED _ON_TRADE_ Serial number is on the trade item ITEM Serial Number FALSE serialNumberLocationCode NOT_MARKED The trade item or its packaging is not marked Serial Number FALSE serialNumberLocationCode UNKNOWN Unknown location of marking SizeType Circumference ClinicalSizeType CIRCUMFERENCE Ci
191. nmentAtmosphericPressu reMinimum UoM Numeric Code List The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected GDSN Notes AVP storageEnvironmentAtmosphericPressur eMaximum AVP storageEnvironmentAtmosphericPressur eMinimum GUDID Code for Storage Type Storage Environment Atmospheric Pressure Handling High Value storageEnvironmentAtmosphericPressu reMaximum UoM storageEnvironmentAtmosphericPressu Po S reMinimum UoM ID coraceHandingHumicityMaximum e UoM Numeric Code List The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected AVP storageEnvironmentAtmosphericPressur eMaximum High Value for GUDID Code for Storage Type Storage Environment Atmospheric Pressure Numeric Code List The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected AVP storageEnvironmentAtmosphericPressur eMinimum Low Value for GUDID Code for Storage Type Storage Environment Atmospheric Pressure Numeric Code List The maximum humidity in percentages that the goods should be stored in storageHandlingHumidityMinimum UoM Numeric Code List The minimum
192. ns 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 Apr 2014 Version 1 All contents GS1 Page 165 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 8 Brand Name FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attrioute Name brandName Definition The recognisable name used by a brand owner to uniquely identify a line of trade item or services This is recognizable by the consumer Data Type Text 1 35 characters GDSN Required MANDATORY 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 Apr 2014 Version 1 All contents GS1 Page 166 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 9 Version or Model Number FDA GUDID Description Data Entry Notes
193. nsactional 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 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 and in the UDI Any other code value published in GDSN will populate a value of FALSE for the GUDID attribute Apr 2014 Version 1 All contents GS1 Page 223 of 256 44 By Expiration Date FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Current GDSN Attribute Definition Data Type GDSN Required GDSN for the FDA Global Unique Device Identifier Database GUDID Webtool lt oO n Ss Z O Z O c en packagingMarkedExpirationDateT ype Indicates the type of expiration date marked on the packaging for example Best Before Date
194. ny manufacturer 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 manufacturer to the GUDID when using a GDSN Data Pool 1 The manufacturer prepares data required by the Global UDI Database 2 The manufacturer provides GUDID data to their GDSN Data Pool of choice 3 The GDSN Data Pool converts the data provided by the manufacturer to the HL7 SPL format refer to the GUDID User Manual for information 4 The GDSN Data Pool registers the manufacturer s product data using the HL7 SPL format in the GUDID 5 The GDSN Data Pool confirms the registration with the Manufacturer once a confirmation from the GUDID is received by the GDSN Data Pool The GDSN provides a secure and easy way for manufacturers to register their product data with any UDI database anywhere in the world via a single connection Refer to the GDSN website for a list of GDSN certified Data Pools http www gs1 org gdsn May 2014 Version 1 1 All contents GS1 Page 17 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID GUDID Data Requirements The Device Identifier DI is the primary key in the UDI database and will be linked to other product data elements Manufacturers will be responsible for submitting and maintaining their own data in the database The U S FDA Global UDI Database GUDID
195. oM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 20 has this as Outer Diameter r iat na A ange Request has been submitted to correct Apr 2014 Version 1 All contents GS1 Page 117 of 256 FDA GUDID Code Attribute Code GDSN for the FDA Global Unique Device Identifier Database GUDID Group GS1 GDSN ae mee Code Value GS1 GDSN Attribute Code Group Description Definition am E re A micrometre is one millionth um Micrometer E oe e cerpin Dimension 4H Micrometre of a metre also termed Micron oe T The international foot is ft_i Feet eye ees Pee capin Dimension FOT Foot defined to be equal to 0 3048 meters 7 An international inch is linicalSizeValue height width depth d fin Inch Dimension INH H29 defined to be equal to 25 4 and netContent millimeters clinicalSizeValue height width depth A yard is It is equal to 3 feet or Iydi Yard and netContent imanen VR Varel 36 inches or 0 9144 meter clinicalSizeValue height width depth a A centimetre is equal to one cm Centimeter and netContent Dimensien eu COMME Me hundredth of a metre ClinicalSizeValue height width depth a 5 A decimetre is equal to one dm Decimeter and netContent Dimension DM Decime tenth of a metre Pore Size Pore Size clinical
196. ol Bq is the SI derived unit of radioactivity One Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second SI uses the becquerel rather than the netContent BQ Becquerel second for the unit of activity measure to avoid dangerous mistakes a measurement in becquerels is proportional to activity and thus a more dangerous source of radiation gives a higher reading A measurement in seconds is inversely proportional netContent BR Barrel netContent BX Box netContent CA Case netContent CN Can netContent CQ Cartridge netContent CT Carton netContent DR Drum netContent DS Display Enzyme linked P immunosorbent assay unit is netContent ELU ELISA Units always associated with a product and a method netContent FH Micromole Che Monthy Gl vel mole netContent HEP Histamine A Histamine equivalent prick Equivalent Prick testing for allergen netContent JR Jar netContent KE Keg Kallikrein Inactivator Unit per Milliliter definition An arbitrary unit of a kallikrein inactivator netContent KIU Kallikrein concentration equal to the inactivator unit concentration at which one milliliter of the mixture contains one unit of the kallikrein inactivator Apr 2014 Version 1 All contents GS1 Page 153 of 256 FDA GUDID Code Attribute Code GS1 GDSN Attribute G
197. om 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 Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public GS1 GDSN Attrioute Name manufacturerDeclaredReusabilityT ype 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 Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list stating if the item can be used again When a value of SINGLE_USE or REUSABLE_SAME_PATIENT are populated for the GDSN attribute manufacturerDeclaredReusabilityT ype 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 manufacturerDeclaredReusabilityType the GUDID will be populated with a value of FALSE signifying the device can be used more than one time 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 Man
198. on 1 3 3 1 3 4 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 database 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 gs1 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 Bar Code and RFID Data Carriers including but not limited to
199. on End Date tramidd yyyy FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below Indicates 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 purchase in the marketplace Drop down is for Webtool only NO U c en 5 lastShipDate Indicates the latest date that the trade item can be shipped This is independent of any specific ship from location Date Time CCYY MM DDTHH MM SS OPTIONAL This date signals that a trade item will no longer be in distribution from the Labeler Apr 2014 Version 1 All contents GS1 Page 175 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 14 Commercial Distribution Status FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV Indicates whether the device is in commercial distribution as defined under 21 CFR 807 3 b In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1 GDSN Attrioute Name Derived by the FDA GUDID based on effectiveDate and lastShipDate Definition N A Data Type N A GDSN R
200. one foot wide and one inch thick Some countries utilize the synonym super foot or superficial foot A A centimetre is equal to one netContent Dimension CM Centimetre hindredth of A metre f A kilometre is one thousand netContent Dimension DK Kilometre 1000 metres netContent Dimension FT Feet netContent Dimension HL Hundred Feet An international inch is netContent Dimension IN Inch defined to be equal to 25 4 millimetres A unit of count defining the clinicalSizeValue height width depth A number of feet 12 inch in and netContent Dimension L gt Bocado length of a uniform width object rae E EA N A unit of count defining the oe e cu depth Dimension LM Linear metre number of metres in length of a uniform width object The metre is the basic unit of netContent Dimension MR Metre length in the International System of Units SI clinicalSizeValue height width depth Mile statute A statute mile of 5 280 feet and netContent Dimaneten Sl mile exactly 1 609 344 meters netContent Dimension TM Thousand Feet netContent Dimension YD Yard The British thermal unit BTU or Btu is a traditional unit of energy It is approximately the amount of energy needed to British thermal heat one pound of water one netContent Enere a unit degree Fahrenheit One Btu is equal to about 1 06 kilojoules It is used in the power steam generation heating and air conditioning industries netContent Energy D30 Terajoule A terajoule is 101
201. 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 packageMarksFreeFrom attribute 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 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details Apr 2014 Version 1 All contents GS1 Page 229 of 256 48 Prescription Use Rx FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates that the device requires a prescription to use Webtool Public ConsumerSalesCondition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required This GDSN attribute is a code list of values signifying how the item is presented for sale to a consumer If a value of PRESCRIPTION REQUIRED is published in
202. opulate 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 active and its contents are not 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 Apr 2014 Version 1 All contents GS1 Page 192 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 25 Package Status FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1 GDSN Derived by the FDA GUDID based on effectiveDate and lastShipDate Definition N A Data Type N A GDSN Required 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 lastShipDate for the package level GTIN in GDSN then the Package Status will be set to No
203. orage Type Handling Environment Atmospheric Pressure Apr 2014 Version 1 All contents GS1 Page 66 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name transportationEnvironmentAtmospheric Pot PressureMinimum UoM transportationHumidityMaximum UoM CDNA EDECEM o Numeric Code List GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected GDSN Notes AVP transportationEnvironmentAtmosphericP ressureMinimum Low Value for GUDID Code for Handling Environment Atmospheric Pressure Numeric Code List The maximum humidity in percentages in which the trade items should be transported transportationHumidityMinimum UoM transportationHumidityMaximum UoM transportationHumidityMinimum UoM Numeric Code List The minimum humidity in percentages in which the trade items should be transported AVP transportationMaximumHumidityMaximum AVP transportationMaximumHumidityMinimum GUDID Code for Storage Type Handling environment humidity Numeric Code List The maximum humidity in percentages in which the trade items should be transported High Value for GUDID Code for Storage Type Handling environment humidity Numeric Code List The minimum humidity in
204. ospheric transportationMinimumTemperature pressure placing the boiling UoM and freezing points of water exactly 100 degrees apart storageHandlingTemperatureMaximu m UoM Kelvin a unit of absolute storageHandlingT emperatureMinimum temperature equal to 1 273 16 UoM of the absolute temperature of transportationMaximumTemperature TEMPIE KEL akim the triple point of water One UoM and kelvin degree is equal to one transportationMinimumTemperature Celsius degree UoM Apr 2014 Version 1 All contents GS1 Page 126 of 256 DISCS DIDE cS Attribute Code Code Value Group GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN er GS1 GDSN Attribute Code Group Description Definition storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum UoM transportationHumidityMaximum Proportion P1 Percent Alunia aee equal to UoM and ae transportationHumidityMinimum UoM 3 The Fahrenheit temperature e e yer aes areas scale the freezing point of ee water is 32 degrees storageHandlingT emperatureMinimum Fahrenheit F and the boiling r Uew Temperature FAH Degree point 212 F at standard transportationMaximumTemperature Fahrenheit atmospheric pressure Uei eel n the ee and transportationMinimumTemperature freezing points of water uon exactly 180 degrees apart Celsius also historically storageHandlingTemperature
205. ot changeable and is relationship dependent specific AVP fDAGUDIDPublishDate Commercial Distribution End Date Time CCYY MM Indicates the latest date that the trade item can be lastShipDate ie shipped This is independent Date ramidd yyyy Beals of any specific ship from location FDA will populate based on the Commercial Distribution Status publication date effectiveDate and the lastShipDate Alternative or Additional Identifiers Direct Marking DM Device Subject to Direct Marking isTradeltemExemptFromDirectPartMark Indicator signifying the trade item is exempt from direct identification marking AVP DM but Exempt ing Boolean according to regulation or aeaa io ete mumccnv ene regulatory filings within the 9 target market LOGICAL POPULATION Logical BOOLEAN value of TRUE from the DM DI Different from Primary DI ea fila bane selina Boolean population of a value of 9 DIRECT_PART_MARKING in additionalTradeltemldentification This is a number or marking DM DI Number directPartMarking Text placed directly on the medical AVP directPartMarking device Secondary DI Apr 2014 Version 1 All contents GS1 Page 56 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Notes Type of the identification system that is being used as GDSN Definition
206. ot in length netContent Area SM Square Metre A square metre is an area of a square whose sides are exactly 1 metre in length netContent Area SY Square Yard The area of a square with sides of one yard three feet thirty six inches 0 9144 metres in length netContent Area YDK Square Yard A square yard is the area of a square with sides of one yard three feet thirty six inches 0 9144 metres in length netContent Count 15 Stick netContent Count 2P Kilobyte A unit of information equal to 108 1000 bytes netContent Count 4L Megabyte A unit of information equal to 10 1000000 bytes netContent Count 5B Batch A unit of count defining the number of batches batch quantity of material produced in one operation or number of animals or persons coming at once netContent Count AD Byte A unit of information equal to 8 bits netContent Count AlU Anti XA Unit A unit of measure for blood potency Units for the anti XA activity which is a measure to the anti coagulating effect at low molecular heparins netContent Count AS Assortment A unit of count defining the number of assortments assortment set of items Apr 2014 Version 1 All contents GS1 Page 132 of 256 1 GDSN for the FDA Global Unique Device I
207. party phone number is TELEPHONE communicationNumber Text 1 70 characters Number assigned to a specific means of communication communicationChannelCode Code List Means used to communicate with another party Value populated for the support contact email is EMAIL Device Status communicationNumber Text 1 70 characters Number assigned to a specific means of communication doesTradeltemContainHumanTissue Boolean 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 AVP does TradeltemContainHumanTissue Apr 2014 Version 1 All contents GS1 Page 58 of 256 FDA GUDID Data Element GS1 GDSN Attribute Name groupedProduct GDSN Data Type Code List GDSN for the FDA Global Unique Device Identifier Database GUDID GDSN Definition GDSN Notes Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item AVP groupedProduct KIT AVP groupedProduct KIT_AND_COMBINATION AVP groupedProduct COMBINATION Premarket exemptFromFDAPreMarketAuthorizatio n Boolean 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 I
208. ped 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 utilized 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 assigned Code Description FDA GUDID Code Attribute 4 GS1 GDSN Code EE Code Group Code Value GS1 GDSN Attribute Valie Pee Definition Loo G Additional Trade Item MODEL_NUMBER Current definition Additional Identification Type Vendor identification number which defines the configuration of the product over and above the Item number Definition for GDSN Major Release 3 x in 2016 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 Apr 2014 Version 1 All contents GS1 Page 70 of 256 FDA GUDID Code Attribute Code Group Catalog Number Code Value GS1 GDSN Attribute Additional Trade Item Identification Type GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value SUPPLIER_ASSIGNED Code D
209. r GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code GPP Peel Pack Peel Pack A package used for sterile products which may be torn open without touching the product inside Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code GPU Packed Unspecified 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 Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code HPR Hamper Hamper Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code HPT Hopper Truck Hopper Truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code HRB On Hanger or Rack in Boxes On Hanger or Rack i
210. rade Name DACON POES Bonne a a information may 1 release of GUDID Alphanum NA Daa beask iectanee Length 80 Ea E May 2014 Version 1 1 All contents GS1 Page 23 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID ae Public AA Te aoe Data Entry Aa Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger He moge pund on tne YES Public or design of a string of letters identifies all can be entered if speealar caret ee acon NA be used to identify specifications within limits set by Catalog Sen aa NO Public ve ier ar pas OO eean m M eee specifications All contents GS1 May 2014 Version 1 1 Page 24 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID NO Public Additional relevant information about the device that is not already captured as a distinct GUDID data attribute Commercial Distribution Indicates the date the DI Record is published and available via Public Search NO Public May 2014 Version 1 1 All contents GS1 Page 25 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Data Element Description Data Entry Notes Required Data Type amp Length Eniry List of V
211. ransactional documents such as packaging shipping and invoice documents A value populated of TRUE for the temporary attribute or of PRODUCTION_DATE for the 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 in the UDI Apr 2014 Version 1 All contents GS1 Page 222 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 43 Serial Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Webtool Required Data Type amp Length Entry List of Values LOV lt oO n Z O New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name serialNumberLocationCode 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 number 1234569 Data Type Text 1 35 characters External Code List GDSN Required OPTIONAL Population Guidance below This GUDID attribute is a Boolean clarifying how the item is controlled Itis 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 tra
212. rcumference SizeType Depth ClinicalSizeType DEPTH Depth SizeType Device Size Text ClinicalSizeType DEVICE_SIZE_TEXT_S Device Size Text specify PECIFY specify SizeType ClinicalSizeType GAUGE PENDING Gauge a eee SizeType Greatest Diameter ClinicalSizeType GREATEST_DIAMETE Greatest Diameter R SizeType ClinicalSizeType HEIGHT Height SizeType ClinicalSizeType LENGTH Length SizeType Needle Gauge ClinicalSizeType NEEDLE_GAUGE Needle Gauge SizeType SizeType SizeType Total Volume ClinicalSizeType TOTAL_VOLUME Total Volume Apr 2014 Version 1 All contents GS1 Page 104 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute ClinicalSizeType GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Width Definition Sterilization Method Moist Heat or Steam Initial Manufacture Sterilization Initial Sterilization Prior to Use AUTOCLAVE Autoclave Steam is a method of sterilisation that utilizes pressure and heat to achieve a sterile environment Sterilization Method Radiation Sterilization Method Ethylene Oxide Initial Manufacture Sterilization Initial Sterilization Prior to Use Sterilization Initial Sterilization Prior to Use BETA_RADIATION Be ec om zia o 2 O w ie oO S aie 35 oD 8a co o 2D
213. re Handling environment transportationMaximumHumidityMaximum humidity transportationMaximumHumidityMinimum AVP transportationEnvironmentAtmosphericPressMaximum Handling environment AVP atmospheric pressure transportationEnvironmentAtmosphericPressMinimum 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 other have a single or recommended value Population of all possibilities can be handled in the GDSN and the GUDID using the following chart Range of Lowest to Highest Minimum or Low Values Field Lowest Value Maximum or High Values Field Highest Value Apr 2014 Version 1 All contents GS1 Page 248 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 Maximum or High Values Field Single Same Value populated in both fields Apr 2014 Version 1 All contents GS1 Page 249 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 59 Unit of Measure SPL Name Storage and Handling Unit of Measure
214. rrently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description Definition where applicable GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code BBL Barrel Barrel A cylindrical packaging whose bottom end is permanently fixed to the body and top end head is either removable or non removable GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code BDG Banding Banding Something that binds ties or encircles the package container to secure and maintain unit integrity GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code BDL Bundle Bundle GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Packaging Type Code BEM Beam Beam GDSN util
215. rring Some organizations 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 organization This step 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 May 2014 Version 1 1 All contents GS1 Page 13 of 256 1 8
216. rstand higher level Tany package packaging configurations Package Indicates the Choose date from Discontinue date this Date particular package dd Discontinuation of discontinuation of configuration is discontinued by the labeler GDSN for the FDA Global Unique Device Identifier Database GUDID evan Public Data Type amp Entry List of New DI Required i o Private Length Values LOV Trigger Status NO Public NO Private NO Public May 2014 Version 1 1 All contents GS1 Page 31 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Public ae ae Data Entry Ao Data Type amp Entry List of New DI i Data Element Description Notes Required Length Values LOV Trigger Ea the base package Package Status he package in fasod on Package NA data NO Public on maen information oes oe Support Phone number Enter 10 digit Can edit add or 1 Required if NO Public Customer Phone number SPL Text 1 1 Contact Phone for the Customer require the use Conditionally contact tobe of or but can Required used by patients enter these ONLY required i Email for the Enter email NO Public ko Gusomercontact adore patnisand Tris emal adress dovcereiteu one hat appears ana SPL Name _ device related M
217. s GS1 Page 146 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress ureMinimum UoM Pound force per The pound force per square inch symbol psi or Ibf in2 or Ibf in2 is a unit of pressure or of stress based on avoirdupois units It is the pressure resulting from a force of one pound force applied to an area of one square inch Other abbreviations are used that append a modifier to psi transportationEnvironmentAtmospheri Pressure PS square inch However the US National cPressureMaximum UoM and Institute of Standards and transportationEnvironmentAtmospheri Technology recommends that cPressureMinimum UoM to avoid confusion any modifiers be instead applied to the quantity being measured rather than the unit of measure 1 For example Pg 100 psi rather than P 100 psig storageHandlingHumidityMaximum UoM storageHandlingHumidityMinimum r UoM transportationHumidityMaximum Proportion 59 Part per million Ulu oC egwali ia UoM and 6 ppm transportationHumidityMinimum UoM A measurement for sound in air and other gases relative to 20 micropascals uPa 2x10 5 Pa the quietest sound a human can hear This is roughly the soun
218. s DI Package Package Discontinue Date 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 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 May 2014 Version 1 1 All oMahiecL s Value Unit of Measure Special Steeages of 256 Draft pending IP Redewibods2St ctitiation 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 Issue No Date of Change 5 9 May 2014 GDSN for the FDA Global Unique Device Identifier Database GUDID Changed By Summary of Change Scott Brown Corrections to the document sections 3 4 5 to correct the
219. s are Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date Identifier Database GUDID be entered as single 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 See the example below In GDSN the following is provided Hierarchy Number 1 ChildTradeltem glob globalTradeitemNumber mradektenNimber tradeltemUnitDescriptor quantityofNextLow erLevelTradeltem 2061414111111c CASE 1061414111111c 5 5 cartons in a case 10614141111110 PACK OR INNER_PA 0061414111111c 4 4 boxes in a carton r e See N A N A 1 Box of Gloves Hierarchy Number 2 a ChildTradeltem glob quantityofNextLow globalTradeitemNumber tradeltemUnitDescriptor amadeitemNimber ei einradaen 4061414111111c CASE 3061414111111c 2 2 cartons in a case 3061414111111c PACK_OR_INNER_PACK 0061414111111c 10 10 boxes in a carton 0061414111111c BASE_UNIT_OR_EACH N A N A 1 Box of Gloves This is converted to the following for population in the GUDID Quantity per package Contains DI Package Notes 1061414111111 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111 5 3061414111111c Indicate
220. s there are 5 packs in the case 3061414111111 10 0061414111111c Indicates there are 10 eaches in the pack 4061414111111 2 3061414111111c Indicates there are 2 packs in the case Apr 2014 Version 1 All contents GS1 Page 185 of 256 GDSN for the FDA Global Unique Device Identifier Database 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 not be deleted Apr 2014 Version 1 All contents GS1 Page 186 of 256 21 Quantity per package FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Public quantityofNextLowerLevelTradeltem 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 Integer DEPENDENT not populated where isTradeltemABaseUnit is TRUE 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 N
221. ssification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This set of attributes will allow for the population of a Pre Market Authorization 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 Premarket Submission Number and GMDN For supply chain use this set of attributes can also provide the UNSPSC code for the device Apr 2014 Version 1 All contents GS1 Page 206 of 256 GDSN for the FDA Global Unique Device Identifier Database 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 added but can not be edited or deleted
222. stering data in the FDA 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 manufacturer to enter and update their data manually directly in their database 2 Bulk data registration direct from a manufacturer 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 manufacturer to register data directly from an internal application such as an ERP to the GUDID The manufacturer must convert their internal data record into the HL7 SPL standard 3 GDSN certified Data Pools can register data on behalf of the manufacturers using the HL7 Structured Product Labeling SPL standard The manufacturer will need list their data pool as their data provider when they create their Labeler profile with the FDA GS1 successfully tested this capability with 8 manufacturers with the support of 1Worldsync and GHX in 2012 during the FDA s user acceptance testing WEG Global UDI gt DELEIER Illustration 2 The GDSN is an Internet based interconnected network of interoperable data pools and a Global Registry the GS1 Global Registry that enables companies around the world to exchange accurate standardised and synchronised suppl
223. t Apr 2014 Version 1 All contents GS1 Page 107 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID The following are the Unit of Measures UoM which are used by FDA and the corresponding UoM used in GDSN FDA GUDID Code s GS1 GDSN p Code Value GS1 GDSN Attribute Code Group netContent Count Code Value DD Description Degree Unit of Angel Definition A measurement of plane angle representing 1360 of a full rotation one degree is equivalent to 1 180 radians netContent Area FTK Square foot A square foot is an area of a square whose sides are exactly 1 foot in length netContent Area INK Square inch A square inch is an area of a square whose sides are exactly 1 inch in length Area CMK Square centimetre A square centimetre is an area of a square whose sides are exactly 1 centimetre in length netContent Area MTK Square metre A square metre is an area of a square whose sides are exactly 1 metre in length netContent Isft_i Square foot sin_i Square inch cm2 Square centimeter netContent m2 Square meter mm2 Square millimeter Area MMK Square millimetre A square millimetre is an area of a square whose sides are exactly 1 millimetre in length Ch French ClinicalSizeValue height width depth and netContent Dimension
224. t Submission FDA Premarket additionalClassificationAge 58 FDA Premarket Number Submission Number ncyName Submission Number For GDS Use Only additionalClassificationAge 5 UNSPSC UNSPSC United Nations Standard ncyName Products and Services Code For GDS Use Only additionalClassificationAge 6 UNSPSC ECCMA UNSPSC Electronic Commerce ncyName Code Management Association For Single Use FALSE Healthcare Trade Item LIMITED_ REUSABLE Manufacturer has indicated that Reusability product may be reused but has provided special instructions limitations or guidelines around the reuse of this trade item For Single Use FALSE Healthcare Trade Item REUSABLE Product can be reused Apr 2014 Version 1 All contents GS1 Page 73 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute CRARCIDRIN KO 5 Code Value GS1 GDSN Attribute where Definition Code Group Value applicable Reusability For Single Use TRUE Healthcare Trade Item REUSABLE _SAME_PA Product can only be reused for the Reusability TIENT same patient For Single Use TRUE Healthcare Trade Item SINGLE_USE Item is not intended to be reused Reusability Labeler DUNS Additional Party DUNS N A Identification Type Labeler DUNS Additional Party DUNS_PLUS_FOUR N A Identification Type MRI Safety Status MR Conditional mRICompatibility MRI_CONDI
225. t an Ambient Temperature Store in a Clean Cool Dry Place Store Away From Sunlight Strong Odours and Chemicals Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight and Freezing Temperatures Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight Before opening store at 5 C 30 C After Opening Keep Refrigerated 5 C and Consume Within 48 hours Drink Chilled Store in a Cool Dry Place Refrigerate After Opening Can Be Kept in the Fridge For 3 Months Text Language qualified 1 1000 characters OPTIONAL This attribute can be populated with any special storage transportation or handling instructions as deemed necessary by the supplier manufacturer Apr 2014 Version 1 All contents GS1 Page 251 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 61 Device Packaged as Sterile FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name LOGICAL POPULATION Definition Indicates the medical device is free from viable microorganisms See ISO TS 11139 lt oO o o Z O lt ES v Cc J initialManufacturerSterilisation Logical BOOLEAN value of TRUE from the population of any value in initialManufacturerSterilisation Typ
226. t 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 Apr 2014 Version 1 All contents GS1 Page 193 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 26 Support Customer Contact Phone FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a contactType b communicationChannelCode c communicationNumber Definition a The general category of the contact party for a trade item for example Purchasing b Means used to communicate with another party c Number assigned to a specific means of communication Data Type a Code List b Code List Multiple Occurrence c Text 1 70 characters Multiple Occurrence GDSN Required OPTIONAL however if any of the three is provided an instance of all three are required Population Guidance below The GDSN attribute contactType signifies which type of contact information is being provided The GDSN attributes communicationChannelCode Apr 2014 Version 1 All contents GS1 Page 194 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID and commun
227. tackable package designed GUDID currently primarily for liquids such as juice or needs a term for the milk code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GNT Net Net A container of meshwork code value however material made from threads or strips GUDID currently twisted or woven to form a regular needs a term for the pattern with spaces between the code The term in threads that is used for holding the description field carrying trapping or confining at right should be something passed to the FDA GUDID Apr 2014 Version 1 All contents GS1 Page 87 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Pallet Box Definition 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 Packaging Type GDSN utilizes the code value howeve
228. tem Number Production data is not stored in UDI or GDSN databases PI Al Production Identifier PI if applicable Application Identifiers Al Production Identifier data will vary by e Expiration Date Al 17 e g 141120 medical device type and manufacturer e Lot Batch Al 10 e g 1234AB current practice e Serial Number Al 21 e g 12345XYZ oe i DI PI UDI GTIN or GTIN Al s UDI sr oveucos o EIET Illustration 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 manufacturer
229. tenuation steps or dilution levels representing the homeopathic potency of a substance using the Korsakovian K method of attenuation commonly denoted as CK1 CK2 CK3 etc Each centesimal attenuation step represents one part source material combined with 99 parts dilution medium commonly denoted as C1 C2 C3 etc netContent Count X_MLM Millesimai LM A count of attenuation steps or dilution levels representing the homeopathic potency of a substance where each attenuation step represents one part source material combined with 49 999 parts dilution medium commonly denoted as LM1 LM2 LMS etc Apr 2014 Version 1 All contents GS1 Page 137 of 256 FDA GUDID Code Attribute Code Code Value Group GS1 GDSN Attribute netContent Code Group Count GS1 GDSN GDSN for the FDA Global Unique Device Identifier Database GUDID Code Value X_MTC Description Mother tincture Dry material Definition A count of a dry crud medical substance Mother tincture when used for homeopathic preparations are liquid preparations obtained by the solvent action of a suitable vehicle upon raw materials The raw materials medical substance are usually in the fresh form but may be dried Mother tinctures for homeopathic preparations may also be obtained from plant juices with or without the addition of a vehicle netContent Count X_SP
230. tes that if there is latex present a label mark must be placed on the packaging 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 Apr 2014 Version 1 All contents GS1 Page 227 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 47 Device labeled as Not made with natural rubber latex FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below Public packageMarksFreeFrom Indication of the food ingredients that the package is marked free from Code List OPTIONAL 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 Apr 2014 Version 1 All contents GS1 Page 228 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID code list However the actual code value is
231. the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code KTB Knockdown Tote Knockdown Tote Bin Bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LAB Label Tag Label Tag Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LID Lip Top Lip Top In packaging the top or bottom of a container usually the part that closes the opening may also be known as cap over or top Apr 2014 Version 1 All contents GS1 Page 90 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID Ci C Bio KO 5 Value Code Description where applicable Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The t
232. the GDSN attribute ConsumerSalesCondition 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 Apr 2014 Version 1 All contents GS1 Page 230 of 256 49 Over the Counter OTC FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates that the device does not require a prescription to use and can be purchased over the counter OTC Webtool i Public ConsumerSalesCondition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required 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 ConsumerSalesCondition 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 Apr 2014 Version 1 All contents GS1 Page 231 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID rr Apr 2014 Version 1 A
233. there appropriate data linkages between internal systems e 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 catalogs or the GDSN Source Data Pool for data synchronization with external users In relationship 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 manufacturer 4 Audit and Evaluate 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 occu
234. tion field at right should be passed to the FDA GUDID Packaging Type Code UNT Unit Unit Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code UVQ Wrapped in Plastic Wrapped in Plastic Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code VEH Vehicles Vehicles Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code VIL Vial Vial Apr 2014 Version 1 All contents GS1 Page 102 of 256 FDA GUDID Code Attribute Code Group Packaging Type Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GS1 GDSN Attribute Packaging Type Code GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Value Code Description where applicable Vehicle in Operating Condition Definition Vehicle in Operating Condition Packaging Type GDSN utilizes the
235. tiple of six 6 A unit of count defining the netContent Count KT Kit number of kits kit tub barrel or pail clinicalSizeValue and netContent Count LK Link inl ea distance equal to 0 01 chain A unit of count defining the netContent Count LR Layer number of layers LM Fifty Millesimal Scale Of Attenuation One millilitre 1 0 ml of the first fifty millesimal attenuation 1LM represents 6 20 x 10 11 of dry crude medicinal substance Impregnate the lactose in a proportion of 1 to 100 beginning with the liquid substance mother tincture then triturate The second and third triturations are carried out in the same way as when starting with solid products netContent Count MLM Millesimal LM A count of a dry crude medicinal substance Mother tincture when used for homeopathic preparations are liquid preparations obtained by the solvent action of a suitable vehicle upon raw netContent Count MTC Mother Tincture materials The raw materials are usually in the fresh form but may be dried Mother tinctures for homeopathic preparations may also be obtained from plant juices with or without the addition of a vehicle Apr 2014 Version 1 All contents GS1 Page 135 of 256 1 GS GDSN for the FDA Global Unique Device Identifier Database GUDID FDA GUDID Code Attribute Code GS1 GDSN Code Code Value GS1 GDSN Attribute Description Definition Code Group Val
236. to correct UoM Length Size Fc 2 F F p i clinicalSizeValue height width depth A A kilometre is one thousand km Kilometer pPcinerecntcnt Dimension KMT Kilometre 1000 metres e e m Meter eal a eee depth pidencion MTR Metre ae Peete Length System of Units SI UoM Length Size PRE Se es ae ma Units ot Measure mm Millimeter ClinicalSizeValue height width depth Dimension MMT Millimetre A millimetre is one thousandth and netContent of a metre 0 001 Length Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure nm Nanometer clinicalSizeValue C45 20 has this as Length code C45 A Change Request has been submitted to correct Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure pm Picometer clinicalSizeValue C52 20 has this as Length code C52 A Change Request has been submitted to correct Apr 2014 Version 1 All contents GS1 Page 114 of 256 1 BY WC10 B D relo t Attribute Code Group GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN and netContent Code Value GS1 GDSN Attribute Code Group Description Definition ae ever ERTS A micrometre is one millionth um Micrometer Se eae Blue eee BS OI Dimension 4H Micrometre of a metre also termed and netConten Micron u
237. tre A litre is defined as a special name for a cubic decimetre 1 L 1 dm3 103 cm3 netContent Volume MLT Millilitre A millilitre is one thousandth of a litre 0 001 Apr 2014 Version 1 All contents GS1 Page 130 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID CRIER Code Group Code Value Description Currently no Definition GDSN or UN Recommendation UoM Volume Units of 20 Value for FDA Measure Total nL Nanoliter clinicalSizeValue PENDING GUDID UoM A Volume Change Request has been submitted to correct Currently no GDSN or UN Recommendation UoM Volume Units of 20 Value for FDA Measure Total pL Picoliter clinicalSizeValue PENDING GUDID UoM A Volume Change Request has been submitted to correct UoM Volume Units of TA Pa Measure Total uL Microliter netContent Volume 4G Microlitre A maalie RE milkonin ai Volume UNAS The international avoirdupois a geil Ib_av Pound grossWeight and netContent Mass LBR Pound pound of exactly 0 45359237 kilogram UoM Weight Units of rr Ton US or short a Measure Weight ston_av Ton grossWeight and netContent Mass STN ton UK Ton US 2000 Lb or 907 Kg ZANZI A gram is defined as one one ring aris e
238. ts GS1 Page 255 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 7 References e For more information on UDI at a global level refer to http www gs1 org healthcare udi e For more information on the IMDRF refer to http www imdrf org e For more information on the U S FDA UDI refer to http www gs 1us org industries healthcare gs 1 healthcare us fda udi e For more information on the GDSN refer to http www gs1 org gdsn e For more information on GS1 Healthcare refer to http Avww gs1 org healthcare e For country support contact your local GS1 Member Organisation http www gs1 org contact Apr 2014 Version 1 All contents GS1 Page 256 of 256
239. ual to 25 4 Circumference millimeters UoM Length Size Pa Pia cee ee r clinicalSizeValue height width depth r A yard is It is equal to 3 feet or Saita SNARARE yd_l Yard and netContent Dimension VRD Verl 36 inches or 0 9144 meter Circumference o E ini i height width A centimetre is equal to one Units of Measure cm Centimeter o ra a i depth Dimension CMT Centimetre hundredth of ee Circumference pode e ini i height width F A decimetre is equal to one Units of Measure dm Decimeter AE aan ey depth Dimension DMT Decimetre tenth ofa SEE Circumference Currently no GDSN Value for FDA GUDID UoM UN UoM Length Size Recommendation Units of Measure fm Femtometer clinicalSizeValue A71 20 has this as Circumference as Fi A 3 ange Reques has been submitted to correct UoM Length Size w DU en eee l p A clinicalSizeValue height width depth A kilometre is one thousand oa km Kilometer nn neat p Dimension KMT Kilometre 1000 metres i E l Th tre is the basic unit of ie bri sata m Meter ClinicalSizeValue height wicih depth Dimension MTR Metre Ena in ne International and netContent f Units SI Circumference System of Units SI UoM Length Size F WOR Rates m 7 Units Gt Measure mm Millimeter clinicalSizeValue height width depth Dimension MMT Millimetre A millimetre is one thousandth of a metre 0 001 Apr 2014 Version 1 All contents GS1 Page 10
240. ubmitted to correct clinicalSizeValue KPA UoM Pressure Units of Measure Pressure mbar millibar Currently no GDSN Value for FDA GUDID UoM UN Recommendation 20 has this as code MBR A Change Request has been submitted to correct clinicalSizeValue MBR Apr 2014 Version 1 All contents GS1 Page 120 of 256 FDA GUDID Code Attribute Code Group Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Code Value Description Definition UoM Pressure Units of Measure Pressure mg TotalVolume Milligram per Total Volume clinicalSizeValue 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 anda GDSN Change request would be entered to support NA M1 C12 H63 MF MK GO UoM Pressure Units of Measure Pressure U L Units per Liter clinicalSizeValue PENDING Currently no GDSN or UN Recommendation 20 Value for FDA GUDID UoM A Question is posed to the FDA to clarify which unit they refer to Apr 2014 Version 1 All contents GS1 Page 121 of 256 FDA GUDID Code Attribute Code Group Code Value
241. ue Group netContent Count NIU Number of International Units A unit of count defining the number of international units The International Unit is a unit of measurement for the amount of a substance based on measured biological activity or effect The unit is used for vitamins hormones some medications vaccines blood products and similar biologically active substances netContent Count PC Piece A unit of count defining the number of pieces piece a single item article or exemplar netContent Count PD Pad A unit of count defining the number of pads pad block of paper sheets fastened together at one end clinicalSizeValue and netContent Count PNT Point A single unit on a scale of measurement as part of an incentive program or pricing structure used as a means of making a quantitative evaluation netContent Count PR Pair A unit of count defining the number of pairs pair item described by two s netContent Count PTN Portion netContent Count QB Page hardcopy A unit of count defining the number of hardcopy pages hardcopy page a page rendered as printed or written output on paper film or other permanent medium netContent Count RL Roll netContent Count SET Set A unit of count defining the number of sets set a number of objects grouped together
242. uidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Indicates the method s of sterilization that can be used for this device P Z cs O initialSterilisationPriorToUse 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 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 This GDSN attribute is a code list of the type s of sterilization which can be performed on a device by the Provider prior to use When this attribute is published a value of TRUE will be populated for the GUDID attribute Requires Sterilization Prior to Use to ror use the value of UNSPECIFIED as the FDA GUDID wil not accept that values Apr 2014 Version 1 All contents GS1 Page 254 of 256 GDSN for the FDA Global Unique Device Identifier Database 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 Apr 2014 Version 1 All conten
243. umber Contains DI Package Package Type Quantity per Package 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 Apr 2014 Version 1 All contents GS1 Page 187 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID This GDSN attribute references the quantity of the child trade item GUDID Contains DI Package which is contained in the GTIN GUDID Package DI Number See the example below In GDSN the following is provided Hierarchy Number 1 p A ChildTradeltem gl quantityofNextL See ee oe epi cee obaifradeltemNu owerlleuckinadel mber tem 2061414111111c CASE 1061414111111c 5 5 cartons in a case 1061414111111c Ga i 0061414111111c 4 4 boxes in a carton v Pa N A N A 1 Box of Gloves Hierarchy Number 2 p ChildTradeltem gl quantityofNextL gr mal ei en ere eee Sbaltradeliamnu owerlevellradel mber tem 4061414111111 CASE 3061414111111 2 2 cartons in a case 3061414111111 oe re 0061414111111 10 10 boxes in a carton ggde e ee N A N A 1 Box of Gloves Quantity per This is converted to the following for population in the GUDID Package DI Number package Contains DI Package Notes 1061414111111 4 0061414111111 Indicates there are 4 eaches in the pack 2061414111111 5 3061414111111 Indi
244. unding atmosphere At sea level Earth s atmosphere actually exerts a pressure of 14 7 psi Humans do not feel this pressure because internal ureMinimum UoM Pressure 64 LRT A pressure of liquid in their transportationEnvironmentAtmospheri g G bodies matches the external A 3 auge cPressureMaximum UoM and pressure If a pressure gauge transportationEnvironmentAtmospheri is calibrated to read zero in cPressureMinimum UoM space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress The bar is widely used in ureMinimum UoM Pressure BAR Bar unit of descriptions of pressure 1 bar transportationEnvironmentAtmospheri pressure 100 kilopascals 0 987 cPressureMaximum UoM and atmospheres transportationEnvironmentAtmospheri cPressureMinimum UoM storageEnvironmentAtmosphericPress ureMaximum UoM storageEnvironmentAtmosphericPress The bar is widely used in ureMinimum UoM Pressure BI Bar descriptions of pressure 1 bar transportationEnvironmentAtmospheri cPressureMaximum UoM and transportationEnvironmentAtmospheri cPressureMinimum UoM 100 kilopascals 0 987 atmospheres Apr 2014 Version 1 All contents GS1 Page 145 of 256 FDA GUDID Code Attribute Code Code Value G
245. undredth 1 100 of a litre Apr 2014 Version 1 All contents GS1 Page 149 of 256 FDA GUDID Code Attribute Code Code Value GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID GS1 GDSN Code Group Description Definition Group netContent Volume c8 Cubic Decimetre A cubic decimetre is the volume of a cube of side length one decimetre 0 1 m netContent Volume cc Cubic Centimetre A cubic centimetre is the volume of a cube of side length one centimetre 0 01 m equal to a millilitre netContent Volume CF Cubic Foot A cubic foot is the volume of a cube of side length one foot 0 3048 m netContent Volume Cl Cubic Inch A cubic inch is the volume of a cube of side length one inch 0 254 m netContent Volume CMQ Cubic centimetre A cubic centimetre is the volume of a cube of side length one centimetre 0 01 m equal to a millilitre netContent Volume co Cubic Meters A cubic metre is the volume of a cube of side length one metre netContent Volume CR Cubic Meter netContent Volume DMQ Cubic decimetre A cubic decimetre is the volume of a cube of side length one decimetre 0 1 m netContent Volume DRA Dram US The dram archaic spelling drachm was historically both a coin and a weig
246. unit of measure and a value c The maximum humidity in percentages that the goods should be stored in Apr 2014 Version 1 All contents GS1 Page 241 of 256 d e GDSN for the FDA Global Unique Device Identifier Database GUDID The minimum humidity in percentages that the goods should be stored in The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality f The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironmentAtmosphericPressureMaximum b storageEnvironmentAtmosphericPressureMinimum c transportationEnvironmentAtmosphericPressMaximum d transportationEnvironmentAtmosphericPressMinimum e transportationMaximumHumidityMaximum f transportationMaximumHumidityMinimum Definition a The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected b The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected C 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 su
247. upplement Number to complete phrase to state Not Required for Kits Updated guidance on how to populate the FDA Premarket Submission 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 May 2014 Version 1 1 All contents GS1 Page 7 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Table of Contents aii 2 Us 1 2 9 iene te ee E eee err E ne pe ee E 94 1 1 Purpose of this DOCUMEN ciei i E EAE NES S EE 94 1 2 Who Will Use this Document secsessiiscinrccenecnenen i a E Y 94 1 3 a E E E E E N E E 94 1 3 1 The GS1 Global Company Prefix GCP s sssssssssesssessresrresnesrresrnrsrrnsrnnsrnnstnnsrnnsrnnsrrnsrn 94 1 3 2 The role the Global Trade Item Number GTIN and Application Identifiers Als 94 1 3 3 Automatic Identification and Data Capture AIDC Marking ccccceeeeeeeseeeeteeeeenees 105 1 3 4 The role of Global Location Number GLN in UDI ecceeceeeeeeeeeeeeeeeeeeeeeeeesseeetenees 105 1 3 5 GDSN Knowledge i ietsvesccchescecstiiy scene acc aa eaan eaaa E aaea sae eae ies 115 1 4 Whats UDI and G UDID teievcesiesscsteveseesvetnieeccelsvevdiet iele beste ea ainera aisi aa ae 116 1 5 Mater Data Management and Governance cccceececeeeeeeeeeeeeaeeeeeaeeeeaeeeeeeessaeesenneetees 116 1 6 Dat
248. us NO Public NO Public May 2014 Version 1 1 All contents GS1 Page 27 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID pee Public AA Te a Data Entry Aa Data Type amp Entry List of New DI Data Element Description Notes Required Length Values LOV Trigger Ee Secondary DI Secondary DI NO Public Number tii il iia Doaz 22 TE 5 0 a Qao ggs 2D oO lt May 2014 Version 1 1 All contents GS1 Page 28 of 256 Data Element Description Data Entry Notes GDSN for the FDA Global Unique Device Identifier Database GUDID Required Data Type amp Length Eniry List of Values LOV New DI Trigger Public Private Status Package DI Package DI Number Lild al i NO Public May 2014 Version 1 1 All contents GS1 Page 29 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Carton Quantity per Add Addition of NO Public be gt 1 ro May 2014 Version 1 1 All contents GS1 Page 30 of 256 Data Element Description Data Entry Notes Package LOV Car cre Package Type Text to describe the outer packaging of the product and enables users to unde
249. value above which the trade item should not be subjected b 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 c The maximum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below The GDSN attributes are pairs of attributes with a minimum and a maximum value This provides a range of applicability for the device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name 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 The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes GUDI ee Wipe GDSN Attributes Storage environment storageHandlingTemperatureMaximum temperature storageHandlingTemperatureMinimum e storageHandlingHumidityMaximum Storage environment humidity storageHandlingHumidityMinimum Storage environment storageEnvironmentAtmosphericPressureMaximum atmospheric pressure storageEnvironmentAtmosphericPressureMinimum AVP Handling environment transportationMaximumTemperature temperature transportationMinimum Temperatu
250. 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 can not be edited or deleted Apr 2014 Version 1 All contents GS1 Page 237 of 256 1 GDSN for the FDA Global Unique Device Identifier Database GUDID 54 Size Unit of Measure FDA GUDID Description The unit of measure associated with each clinically relevant size Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment clinicalSizeUoM Definition The value to denote the dimensional size which is Recommendation 20 code list Data Type Code List UoM qualifier GDSN Required OPTIONAL Final Deployment Attribute Name clinicalSizeValue Apr 2014 Version 1 All contents GS1 Page 238 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 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 syring
251. vice Information Device Identifier DI Information EAN UCC numbering structures will be used for the identification of trade items All of them will be considered as 14 digit Global Trade Item Number GTIN Must be present to enable data to be presented to trade item catalogue Must be submitted by the owner of the data who may be the original manufacturer the importer the broker or the agent of the original manufacturer This field is mandatory within the Global Data Synchronization work process The amount of the trade item contained by a package usually as claimed on the label For example Water 750ml net content 750 MLT 20 count pack of diapers net content 20 ea In case of multi pack indicates the net content of the total trade item For fixed value netContent UoM Numeric Code List trade items use the value claimed on the package to avoid variable fill rate issue that arises with some trade item which are sold by volume or weight and whose actual content may vary slightly from batch to batch In case of variable quantity trade items indicates the average quantity This GTIN should be the lowest level for the hierarchy Numeric 14 globalTradeltemNumber Characters GTIN of a unit of use as defined by the FDA This is a lower level r fDAUnitOfUseGTIN GTIN Gate chien is canielined in te AVP fDAUnitOfUseGTIN Trade Item Identification of a party by use of This pair o
252. ving high tensile strength and Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BME Blister Pack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA Packaging Type Code BOB Bobbin Apr 2014 Version 1 All contents GS1 Page 77 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description FDA GUDID Code Attribute at where Definition GS1 GDSN Code Code Value GS1 GDSN Attribute Code Group Value GUDID applicable Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BOT Bottle Bottle A container 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 c Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA
253. will be printed on the packaging and in the UDI Apr 2014 Version 1 All contents GS1 Page 221 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID 42 Manufacture Date FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Webtool Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Temporary population until final GDSN deployment lt oO n Z O Z O c or 5 isTradeltemManagedByManufactureDate Definition Indication whether the trade item is managed by manufacture date A positive response indicates the manufacturer utilizes the manufacture date to control the item instead of lot and batch numbers Data Type Boolean GDSN Required Optional Final Deployment Attribute Name tradeltemDateOnPackagingTypeCode coming in Major Release in 2016 Definition Indicates the type of date marked on the packaging for example Best Before Date Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN isTradeltemManagedByManufactureDate It will be deployed into the GDSN Schema in 2016 into a final solution This GUDID attribute is a Boolean clarifying how the item is controlled Itis 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 t
254. y chain data with their trading partners The Global Data Synchronisation Network GDSN enables manufacturers 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 manufacturers 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 May 2014 Version 1 1 All contents GS1 Page 16 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID US FDA GUDID Oe HOSPITAL PROVIDER EU UDID sossocscoscoscosoecoecees gt GPO MANUFACTURER JAPAN UDID BB v MANUFACTURER e lt gt MANUFACTURER es Pa MANUFACTURER e e Illustration 3 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 manufacturers 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 the particular UDI database The GDSN provides a means for a
255. y of the data elements are locked and can no longer be edited Apr 2014 Version 1 All contents GS1 Page 220 of 256 41 Lot or Batch Number FDA GUDID Description Data Entry Notes Edit Rules After Grace Period Required Data Type amp Length Entry List of Values LOV New DI Trigger Public Private Status GS1 GDSN Attribute Name Definition Data Type GDSN Required Population Guidance below GDSN for the FDA Global Unique Device Identifier Database GUDID Yes No O Public Z hasBatchNumber 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 items 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 Boolean OPTIONAL This attribute is a Boolean clarifying how the item is controlled Itis 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
256. ype Code DSK Double length Skid Double length Skid Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DTB Double length Tote Bin Double length Tote Bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DUF Duffelbag Duffelbag Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field Packaging Type Code EGG Egg Crating Egg Crating In containers and shipping devices usually describes a type of interior dunnage which allows the contents to be individually segregated horizontally and vertically to provide protection Apr 2014 Version 1 All contents GS1 Page 85 of 256 GDSN for the FDA Global Unique Device Identifier Database GUDID Code Description where Definition FDA GUDID Code Attribute GS1 GDSN Code Code Value GS1 GDSN Attribute Code Group Value at right should be passed to the FDA GUDID applicable during transportation and storage Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term

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