Medical Equipment Labels

1. A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the medical device labeler and the specific version or model of a device; and
2. A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
   • The lot or batch number within which a device was manufactured;
   • The serial number of a specific device;
   • The expiration date of a specific device;
   • The date a specific device was manufactured;
   • The distinct identification code required by § 1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

UDI Compliance Dates

5 years after publication of the final rule (September 24, 2018)

• A class II medical device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the medical device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
• The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
• Data for class I medical devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b).

7 years after publication of the final rule (September 24, 2020)

• Class I medical devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.

UDI Resources

• U.S. Food & Drug Administration: Unique Device Identification
• U.S. Food & Drug Administration: Compliance Dates for UDI Requirements
• U.S. Food & Drug Administration: Product Classification
• U.S. Food & Drug Administration: UDI Resources
• Global Unique Device Identification Database (GUDID)

Benefits of UDI

• UDI enables fast and efficient medical device identification and reduces medical errors associated with data collection
• UDI allows accurate medical device tracking and reporting and enables defective medical device identification and remediation
• UDI enhances the FDA’s ability to monitor the medical devices in the market through a clear and standardized way to document medical device use
• UDI allows manufacturers, distributors and providers to better manage medical device recalls
• UDI helps secure a global distribution chain, prevent counterfeiting, and prepare for medical emergency logistics
• UDI develops a globally-recognized medical device identification system

UDI Applications with Barcode, DataMatrix, or RFID Encoding

• Patient & Staff Identification
• Lab Specimen & Medication Labeling
• Laboratory Vial, Tray & Rack Identification
• Medical Equipment & Supply Labeling
• Hospital Property Tracking
• Location Identification & Wayfinding
• Warehouse Management Solutions