Hospitals, pharmaceutical companies, and medical device manufacturers worldwide trust Express when it comes to custom identification solutions.
All unique device identification (UDI) labels are custom-designed to meet your identification requirements, and are durable enough to withstand chemical or high temperature disinfection and sterilization. With data integrity and read-rates that do not degrade over time, barcode, data matrix, and RFID technology allow you to track assets through any hospital, lab, or medical facility.
Unique Device Identification (UDI) Solutions
- Drug Identification & Medication Management
- Specimen Collection & Blood Infusion Safety
- Surgical Instrument Identification & Sterilization
- Patient Identification
Healthcare & Medical Unique Device Identification (UID) Labels
Unique Device Identification (UDI) is a Food and Drug Administration (FDA) regulation that requires designated medical devices to adhere to certain labeling standards. The UDI system requires medical device labelers to include a unique device identifier (UDI) on all device labels and packages to identify medical devices throughout their distribution and use. Each UDI label must include the UDI information in human-readable text and in a form that uses automatic identification and data capture (AIDC) technology (i.e., barcode or datamatrix). The FDA requires device labelers to directly mark UDI labels on devices intended for more than one use, and devices intended to be reprocessed before each use. UDI also requires medical device labelers to record device attributes in the Global Unique Device Identification Database (GUDID).
Does UDI Apply to Me?
UDI applies to medical device “labelers.” A medical device “labeler” is any person who applies a label to a medical device or modifies the label with the intent that the medical device will be commercially distributed without any subsequent replacement or modification of the label. The addition of the name and contact information of a person who distributes the device, without making any other changes to the label is not a modification for the purposes of determining whether a person is a labeler. In most instances, the labeler is the medical device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.
A UDI is a unique numeric or alphanumeric code that consists of two parts:
- 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
- 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.
- 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
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