Unique Device Identification (UDI)

The Food and Drug Administration (FDA) has issued a rule that requires medical device manufacturers to label their products with a unique device identifier (DI) and production identifiers (such as lot number, serial number, manufacture date and expiration date). Labeling will be reflected in barcode and plain text format.

Global Unique Device Identification Database (GUDID)

The FDA also created the GUDID where manufacturers will enter the device and production identifiers. This database will be searchable by the public through AccessGUDID.

Benefits of a UDI System

UDI labeling will enable the quick and definitive identification of medical devices in the case of adverse events or recalls. Scanning barcodes will streamline inventory management throughout the supply chain, as well as providing a standardized way to document device use in electronic medical records. For more information and for the full text of the rule, visit the FDA's website here.

Download ACUTE Innovations® UDI Information

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