Healthcare & Medical Device Labeling

Unique Device Identifier

Build reliable medical device labeling workflows with UDI-ready barcode, RFID, printing, scanning, and labeling solutions from Barcode Factory.

UDI Medical Devices Barcoding RFID Healthcare

Understanding UDI

What Is a Unique Device Identifier?

A Unique Device Identifier, or UDI, is used to identify medical devices through distribution and use. The FDA's UDI system establishes a standardized approach for identifying devices and requires applicable device labels and packages to carry UDI information in human-readable and machine-readable forms.

Why UDI Matters

UDI creates a consistent way to identify medical devices as they move from manufacturing and distribution into healthcare environments. The system is designed to support more accurate device identification and information throughout the device lifecycle.

Who Uses UDI?

UDI applies across a broad range of medical devices, from surgical instruments and implants to diagnostic equipment and other healthcare products. Device labelers are generally responsible for placing the UDI on applicable device labels and packages and submitting required device information to GUDID.

Break Down the Identifier

UDI Is Built From Two Key Components

The FDA describes a UDI as consisting of a Device Identifier and, when applicable, Production Identifier information.

DEVICE IDENTIFIER

DI — Device Identifier

The mandatory, fixed portion of the UDI that identifies the labeler and the specific version or model of a device.

PRODUCTION IDENTIFIER

PI — Production Identifier

A conditional, variable portion that can identify information such as lot or batch number, serial number, expiration date, or manufacturing date when included on the label.

See It on the Label

Human-Readable + Machine-Readable

Design Labels That Make Device Data Easy to Capture

UDI labeling can combine human-readable information with machine-readable barcode technology. This allows people to identify the device while scanners and other data-capture systems can capture the identifier electronically.

Human-readable UDI information
Machine-readable barcode data
Device and production information
Durable labels for demanding healthcare environments
Options for barcode and RFID-based identification

Medical Device

Example Surgical Instrument

Device Identifier (01) 00812345678901

Lot Number (10) LOT240918

Expiration (17) 300930

Serial (21) 00012345

(01)00812345678901(17)300930(10)LOT240918(21)00012345

Illustrative example only — actual UDI content and formatting depend on the device and applicable requirements.

Barcode Factory Solutions

Everything You Need to Build the Labeling Workflow

UDI labeling is more than a barcode. Barcode Factory can help you select the labels, printers, scanners, RFID technology, and healthcare equipment that fit your application.

Medical Device Labels

Select labels, adhesives, and materials designed for healthcare applications and demanding storage or environmental requirements.

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Barcode Printing

Produce machine-readable labels in-house using thermal printers matched to your label material, size, and application.

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RFID Identification

When RFID is appropriate for your workflow, custom RFID labels can combine printed information with encoded electronic identification.

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Scanning & Data Capture

Connect device identification with scanners and healthcare data capture workflows for faster, more consistent identification.

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UDI Database

Understanding GUDID & AccessGUDID

The FDA's Global Unique Device Identification Database, or GUDID, contains the device identifier and associated identifying information submitted by device labelers.

AccessGUDID is a separate searchable database that allows patients, caregivers, healthcare providers, hospitals, industry, and others to search device identification information.

UDI Resources

FDA UDI Basics → FDA UDI System → Search AccessGUDID → FDA UDI Resources →

Healthcare Labeling

UDI Is Part of a Larger Healthcare Identification Workflow

Medical device identification often intersects with inventory management, point-of-care workflows, asset tracking, specimen management, and patient care. Barcode Factory offers healthcare technologies that can support these connected workflows.

Medical Device Tracking

Capture device information at receiving, inventory, point of care, maintenance, and other workflow stages.

Healthcare Labeling

Support device, specimen, pharmacy, laboratory, patient, and inventory labeling applications with specialized media.

Data Capture

Use barcode scanners, mobile computers, RFID technology, and printers to connect physical identification with digital records.

Need Help With Your UDI Labeling Workflow?

Barcode Factory can help you evaluate the right combination of labels, barcode printers, scanners, RFID technology, and healthcare equipment for your medical device identification application.

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