Blizzard

FDA UDI

Class I (US FDA UDI)

by Blizzard Protection Systems Limited

Identity

Trade Name: Blizzard FDA UDI
Generic Name: Hypothermia-prevention whole-body suit FDA UDI
Device Name: Blizzard Casualty Trauma Blanket XL - Green FDA UDI
Model / Reference: BH-07 FDA UDI
Description: Blizzard Casualty Trauma Blanket XL - Green FDA UDI

Identifiers

Catalog Number: BH-07 FDA UDI
Primary DI / UDI-DI: 05060297210082 FDA UDI
FDA Product Code: KME FDA UDI
GMDN Term: Hypothermia-prevention whole-body suit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Hypothermia-prevention whole-body suit

Blizzard by Blizzard Protection Systems Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Thermoflect — Encompass Group, L.L.C. · Class I
Thermoflect — Encompass Group, L.L.C. · Class I
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VYGON — Vygon Corp. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Blizzard Protection Systems Limited

Sources (1)

FDA UDI 33b00711-094b-4533-9467-e2b34fc2193b 34 fields · synced May 30, 2026