Download GUDID

Leveraging GDSN for the FDA Global Unique Device Identifier Database (GUDID) Implementation Guideline
Release
Date of Change
Changed By
Summary of Change
Safety Status, Size Type, Size Value, Size Unit of
Measure, Size Type Text, High Value, Low Value,
Unit of Measure, Special Storage Conditions,
Sterilization Method
Updated the GUDID Data Type field with the SPL
Text for- Version or Model Number, Device
Description, DI Record Publish Date (Note: date
format is different between the Web Portal and
the SPL Message), Commercial Distribution End
Date (Note: date format is different between the
Web Portal and the SPL Message), Package DI
Number, Package Discontinue Date (Note: date
format is different between the Web Portal and
the SPL Message), Support Contact Phone, Device
Exempt from Premarket Submission, Supplement
Number, Product Code, Code (Split into two
parts- GMDN Preferred Term Code and a new
attribute FDA Preferred Term Code), MRI Safety
Status, Storage and Handling Type, Unit of
Measure
Updated the GUDID Length field with SPL text
for- Primary DI Number, Unit of Use DI Number,
DM DI Number, Secondary DI Number, Package
DI Number, Contains DI Package, Device , Code
(Split into two parts- GMDN Preferred Term Code
and a new attribute FDA Preferred Term
Code)Exempt from Premarket Submission, FDA
Premarket Submission Number, Supplement
Number, Product Code, MRI Safety Status,
Storage and Handling Type, Unit of Measure
Updated the GUDID Values/Terminology field with
the SPL Text for- Device Exempt from Premarket
Submission
Added, updated, and deleted codes values for the
Clinical Size Type- Angle, Area/Surface Area,
Outer Diameter, Pore Size, Pressure, and Width
Release 2.0, Ratified, Oct 2015
© 2015 GS1 AISBL
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