Can you produce FDA UDI-compliant device labels?

Yes. We encode the device identifier and production identifiers in a GS1 DataMatrix with matching human-readable text, on durable substrates that survive sterilization, and support serialization for unique device identification.

Do your labels survive freezing and autoclaving?

Our cryogenic and specimen constructions are rated for deep-freeze and liquid nitrogen (-196°C) and autoclave sterilization, with adhesives engineered to stay put on tubes, vials, and bags.

Labels & Preprinting

Compliance

Healthcare, UDI & Lab Labels

FDA UDI device labels with GS1 DataMatrix, specimen and cryogenic labels, patient wristbands, and ISBT 128 blood-bank labels — built for legibility and adhesion.

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Overview

Healthcare labeling has to stay readable through sterilization, freezing, and handling — and often carry a regulated identifier. We produce FDA UDI device labels, specimen and cryogenic labels, patient wristbands, and ISBT 128 blood-bank labels with the durability and serialization these applications demand.

UDI compliance

The FDA UDI rule requires a device identifier (DI) and production identifiers (lot, serial, expiry) in both machine-readable (GS1 DataMatrix) and human-readable form. We encode and lay out UDI to spec.

GS1 DataMatrix with DI + PI (lot, serial, expiry)
Human-readable interpretation alongside the symbol
Serialization and unique device identifiers

Specimen, cryo & blood-bank

Cold-chain and clinical labels need adhesives and facestocks that survive extremes and stay stuck to tubes, bags, and skin.

Cryogenic labels rated to LN₂ (-196°C) and autoclave
Specimen and pharmacy labels for tubes, vials, and bags
Patient wristbands printed for legibility and comfort
ISBT 128 / DIN blood-bank label formats

Example specifications

UDI device

2" x 1" · polyester · GS1 DataMatrix + HRI

Cryo specimen

Wrap-around · freezer-grade · LN₂ rated

Patient wristband

Direct thermal · antimicrobial options

Blood bag

ISBT 128 · self-laminating construction

Common labels for this application

Recommended materials

Constructions we commonly use for this application. We'll confirm the exact facestock, adhesive, and finish for your surface and environment.

Material	Adhesive	Finish	Temp range	Print method	Best for
Polyester (PET) White / clear / silver polyester	High-tack permanent	Topcoated for scratch resistance	-40°F to 300°F	Thermal transfer (resin) / Color	Asset tags, chemical & outdoor durability
Polyimide Amber / white polyimide	High-temperature silicone/acrylic	Topcoated	-100°F to 700°F	Thermal transfer (resin)	Circuit boards, wave-solder, extreme heat
Freezer-Grade Paper or polypropylene	Cold-temp / deep-freeze acrylic	Topcoated	-80°F to 120°F (LN₂ options)	Direct thermal / Thermal transfer	Cold chain, specimen, blood bank, frozen food
Tamper-Evident Destructible vinyl / void polyester	Permanent, high-bond	Matte / VOID pattern	-20°F to 200°F	Thermal transfer / Color	Security seals, warranty, asset control
RFID Inlay Stock Paper / PET with embedded UHF inlay	Permanent acrylic (on-metal options)	Printable topcoat	-40°F to 185°F	RFID print-and-encode	Item-level, carton, pallet & asset RFID