Medical Device Labeling

A UDI – which is a unique numeric or alphanumeric code – consists of two parts, the Device Identifier (DI) and the Production Identifier (PI). The Device Identifier (DI) is a mandatory, fixed portion that identifies the labeler and the specific version or model of a device. An example of this type of identifier is a GTIN. The Production Identifier (PI) is a conditional, variable portion of the UDI that identifies one or more of the following when included on medical device labeling:

Lot or batch number
Serial number
Expiration date (YYYY-MM-DD format required)
Manufacture date (YYYY-MM-DD format required)
Distinct identification code required by 21CFR1271.290 for any human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device.

Class I Devices only require the Device Identifier (DI).

Class II and III Devices require both the Device Identifier (DI) and Production Identifier (PI).

The UDI must be presented in two forms:

Easily-readable plain text
Automatic Identification and Data Capture (AIDC) technology

Medical Device Labeling Material Considerations

Imprint Enterprises offers Zebra UDI label solutions for nearly any medical device labeling application.

Largest Offering of Pre-Tested Materials
Labels, Tags, Receipt Paper, Wristbands and Ribbons
Over 500 ZipShip items = Convenience
Over 80 pre-tested Materials in our Selector Guide
Access to many more materials through Supplies R&D
Including innovative products:
- IQ Color
- Z-Slip
- Z-Band UltraSoft Wristbands

Quality is assured.

Imprint never substitutes materials, which ensures consistent print quality without the need to adjust darkness settings.
Zebra is ISO 9001-2008 certified, which means there are standard and consistent processes in place to ensure high-quality finished products.
Zebra has a computerized vision inspection system to ensure registration of pre-printed color, logos and text.

UDI Labeling

Imprint Enterprises offers UDI medical device labeling solutions from Zebra Technologies. Zebra Z-Select 4000T labels are ideal for UDI carton labeling. These UDI labels can be used with applicators.