Identity
- Trade Name
- Blizzard FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- Blizzard Trauma Blanket EUDAMEDBlizzard AMB Trauma Blanket - 3 layer green full length blanket with side access to arms with hook and loop closure. FDA UDI
- Model / Reference
- BPS-33 EUDAMEDFDA UDIBPS-01 EUDAMED
- Description
- Blizzard AMB Trauma Blanket - 3 layer green full length blanket with side access to arms with hook and loop closure. FDA UDI
Identifiers
- Catalog Number
- BPS-33 FDA UDI
- Primary DI / UDI-DI
- 05060297210020 EUDAMEDFDA UDI
- Basic UDI-DI
- 506029721BPSRangeBC EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
- GMDN Term
- Hypothermia-prevention whole-body suit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hypothermia-prevention whole-body suit
Blizzard by Blizzard Protection Systems Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypothermia-prevention whole-body suit.
- Hypothermia Management Kit, (TMM-HMK) — Altitude Technologies Inc. · Class I
- Thermoflect — Encompass Group, L.L.C. · Class I
- Thermoflect — Encompass Group, L.L.C. · Class I
- Hypothermia Management Set - Bag (OR) and Grid (8 cell) — SAFEGUARD US OPERATING, LLC · Class I
- Thermoflect — Encompass Group, L.L.C. · Class I
- Thermoflect — Encompass Group, L.L.C. · Class I
- Thermoflect — Encompass Group, L.L.C. · Class I
- VYGON — Vygon Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blizzard Protection Systems Limited
Sources (2)
- FDA UDI a11cf716-4301-4f53-9af8-d472a2283349 34 fields · synced Jun 18, 2026
- EUDAMED abe536ce-ea55-4c2e-a736-cebc50675d3a 61 fields · synced Jun 18, 2026