UDI (Unique Device Identifier)
An FDA-mandated identifier for medical devices that includes a device identifier (DI) and a production identifier (PI) — the foundation of device traceability.
The FDA's Unique Device Identification (UDI) system requires that most medical devices bear a unique identifier consisting of a Device Identifier (DI) — which identifies the specific device version and model — and a Production Identifier (PI) — which includes the serial number, lot number, and/or manufacture/expiration date. The UDI appears on device labels as both human-readable text and a machine-readable barcode or RFID.
For DME suppliers, UDIs on equipment labels provide a standardized way to capture device identity at check-in and check-out. Scanning the UDI barcode can automatically populate serial number, device model, and manufacturer information without manual data entry — reducing errors and speeding up receiving and tracking workflows.
The FDA Global UDI Database (GUDID) provides public access to device reference information associated with each DI, including the device name, device class, sterilization method, and whether the device is reusable. Suppliers can use this to verify device specifications during intake.
CMS has signaled interest in UDI capture at the claims level — some future billing requirements may mandate UDI documentation for certain device categories, making early adoption of UDI-aware tracking systems a forward-looking compliance investment.