Identity
- Trade Name
- Hypothermia Management Set FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- HYPOTHERMIA MANAGEMENT SET 1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Ready-Heat warming blanket WARNING: Do not place Ready-Heat on exposed skin. FDA UDI
- Model / Reference
- 00 FDA UDI
- Description
- HYPOTHERMIA MANAGEMENT SET 1 ea - 7.5" x 6.5" Blizzard Light Blanket, 1 ea - 34" x 48" Ready-Heat warming blanket WARNING: Do not place Ready-Heat on exposed skin. FDA UDI
Identifiers
- Catalog Number
- 59-120 FDA UDI
- Primary DI / UDI-DI
- M68959120000 FDA UDI
- FDA Product Code
- IMD FDA UDIKME FDA UDI
- GMDN Term
- Hypothermia-prevention whole-body suit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 FDA UDI880.6060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hypothermia Management Set by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI b78a6d56-7714-4d43-824d-9c217366a62b 35 fields · synced Jun 1, 2026