UDI (FDA / GS1)

UDI medical-device identifier, traceability across the health care supply chain.

Definition

UDI makes each device traceable from manufacture to patient. The DI identifies the model and manufacturer (often a GS1 GTIN); the PI carries lot, serial number, expiry and manufacturing dates. DIs are published in the FDA's GUDID database and flow through GDSN catalogs and 856 ASNs.

Origin

Mandated by the FDA UDI Rule (21 CFR Part 830, 2013) and, in Europe, by Regulation (EU) 2017/745 (MDR); GS1 is an accredited issuing agency for UDIs.

Example in context

(01)00614141999996(17)271231(10)LOT42 — the DI in AI (01) GTIN, followed by expiry date (17) and lot (10) forming the PI on the device label.

Related terms

• GTIN — the GS1 key used as the Device Identifier.
• GS1 Healthcare — the GS1 sector group for healthcare.