2: Terminology Standards and Tools
AccessGUDID
The Global Unique Device Identification Database (GUDID – pronounced “Good ID”) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). NLM and the FDA created the AccessGUDID portal to make device information in the GUDID available for everyone including patients, caregivers, healthcare providers, hospitals, and industry.
UDIs are created based on international standards for unique identification. Private organizations, called "Issuing Agencies," are accredited by the FDA to operate a system for the issuance of UDIs based on these standards.
A UDI is composed of two parts (UDI = DI + PI):
- Device Identifier (DI) - unique numeric or alphanumeric code specific to a device version or model.
- Production Identifier(s) (PI) - numeric or alphanumeric codes that identify production for a device and can include the lot or batch number, serial number, expiration date, date device manufactured.
A UDI appears in plain text and machine-readable format. Below is an example of a UDI from GS1, one of the FDA-accredited issuing agencies. In GS1’s systems, the numbers in the parentheses indicate the different parts of the UDI.
Device Identifier (DI): 12345678901234
Production Identifiers (PI):
- Expiration Date: 140102
- Manufacturing Date: 100102
- Lot Number: A1234
- Serial Number: 1234
References
"AccessGUDID - ABOUT AccessGUDID." U.S. National Library of Medicine, National Institutes of Health, https://accessgudid.nlm.nih.gov/about-gudid.