GS1 US Unique Device Identification Help Center
For Resolving GUDID Data Deficiencies
Use these resources to help you resolve your GUDID data efficiencies
- GS1 Standards Resources for U.S. FDA UDI Implementation Support – A library of resources, tools, and educational courses to help you on your implementation journey.
- Implementation Guideline - Using the GS1 System for U.S. FDA Unique Device Identification (UDI) Requirements - To help you implement GS1 Standards to meet certain aspects of the U.S. FDA UDI Rule.
Resources to Help You Resolve Your Specific GUDID Data Deficiency Issue
- Implementation Guideline - Using the GS1 System for U.S. FDA Unique Device Identification (UDI) Requirements – See Section 2.1 Global Trade Item Number® to support proper GTIN® construction.
- Check Digit Calculator - The check digit is calculated from all the other numbers in the barcode and helps to confirm the integrity of your barcode number. The last digit of a barcode number is a calculated check digit. Use this free GS1 US tool to calculate the last digit.
- GTIN Format Diagram - This table illustrates the GTIN format for GTIN-12, GTIN-12 in a 14 digit format, and GTIN-14.
- Check Digit Calculator - The check digit is calculated from all the other numbers in the barcode and helps to confirm the integrity of your barcode number. The last digit of a barcode number is a calculated check digit. Use this free GS1 US tool to calculate the last digit.
- GS1 US Data Hub ® | Product - The tool allows you to properly create, manage and share GS1 Standards-based barcodes, GTINs, and U.P.C.s.
U.S. FDA Resources
- U.S. FDA GUDID User Manual – Unlocking Device Records for Editing - This document provides device labelers guidance on unlocking device records to efficiently manage their devices identification data in the GUDID to ensure accuracy.
- U.S. FDA GUDID User Manual - This document is intended primarily to provide information about submitting data to the GUDID database for device Labelers.
- U.S. FDA UDI Help Desk – If you have technical GUDID support questions, please use this link to reach out directly to the U.S. FDA help deck.
Global Trade Item Number Formats
The GTIN is the globally unique GS1 Identification Key used to identify “trade items” (i.e., products and services that may be priced, ordered or invoiced at any point in the supply chain). GTINs are assigned by the brand owner of the product and are used to identify products as they move through the global supply chain to the hospital or ultimately the patient.
The GTIN uniquely identifies a product at each packaging level (e.g., a box of 15 Brand X tissues; a carton of six boxes of Brand X tissues; etc.). GTINs can be encoded into barcodes and used in supply chain transactions (e.g., purchase order; invoice; etc.) to promote accurate product identification.
The table below illustrates GTIN formats.
Additional Resources
If you have additional questions please contact the GS1 US UDI Help Center at udiDataQuality@gs1us.org or a +1.800.761.4872.
*For information about the rule, see the U.S. FDA Unique Device Identification System
Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.
GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.