Unique Device Identification

U.S. Food and Drug Administration (FDA) has established a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in a human and machine-readable format. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the FDA at AccessGUDID.

The UDI system, which is being phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. FDA states UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.

• GS1 is the most widely used supply chain standards system in the world.
• The GS1 Standards are used globally by manufacturing companies to ensure data captured from GS1 barcodes are unambiguous, and can electronically communicate this data to inventory management systems.
• The GTIN and other key product identifiers are automatically identified when the barcode is scanned. For example, when scanning a serial number/barcode, a “(21)” will appear before the actual serial number. This notifies any GS1 compliant scanner or system that the numbers after the “(21)" are a serial number and not a random set of numbers.
• To learn more about GS1 Healthcare, please visit www.gs1.org/healthcare