A unique device identification system established by the U.S. Food and Drug Administration (FDA) to adequately identify medical devices sold in the United States, from manufacturing through distribution to patient use. The system is designed to help health care providers and consumers by enabling faster recalls or discoveries of flawed devices, a better assessment of device performance, improved inventory management and more informed patient treatment.
This requires device labelers (typically the manufacturer) to include a unique device identifier on device labels and packages. Each device is to be labeled with a unique numeric or alphanumeric code including information to identify the manufacturer and model of a device, as well as the lot or batch number, serial number, expiration date, date of manufacture, and distinct identification code for products regulated as devices.
The information must be in two forms: plain text and a machine-readable form, and must be submitted to the Global Unique Device Identification Database (GUDID). This information also is available to the public at Access GUDID. Database users can search on specific devices and download information on every device entered into the database.