A distinctive code assigned to medical devices, providing a globally recognized and unique identification for each device. UDI facilitates traceability, enhances patient safety, and streamlines device recalls.
The portion of the UDI that identifies the specific version or model of a device, allowing for easy differentiation among similar devices from the same manufacturer.
The section of the UDI that includes information such as lot numbers, serial numbers, expiration dates, and manufacturing dates, providing details about the production history of a specific device.
A centralized repository managed by the FDA that stores key information about each medical device with a UDI. Accessible to the public, it serves as a valuable resource for healthcare providers, regulators, and patients.
The process of encoding the UDI into a machine-readable barcode, facilitating quick and accurate identification of medical devices during various stages of the supply chain and healthcare delivery.
Technologies like barcoding and RFID (Radio-Frequency Identification) used to automatically collect data, including UDIs, for efficient inventory management and tracking.
The adherence of medical device manufacturers to regulatory requirements for assigning and labeling devices with UDIs. Compliance ensures standardized identification and reporting.