Identity
- Trade Name
- HI-VIS Emergency Blanket FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- The HI-VIS Emergency Blanket provide a passive remedy to help manage hypothermia in emergency situations. This device will utilize the patient’s body heat to try and preserve the core body temperature. FDA UDI
- Model / Reference
- 02 FDA UDI
- Description
- The HI-VIS Emergency Blanket provide a passive remedy to help manage hypothermia in emergency situations. This device will utilize the patient’s body heat to try and preserve the core body temperature. FDA UDI
Identifiers
- Catalog Number
- 04-106 FDA UDI
- Primary DI / UDI-DI
- M68904106020 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
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hypothermia-prevention whole-body suit
HI-VIS Emergency Blanket by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hypothermia-prevention whole-body suit.
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- Thermoflect — Encompass Group, L.L.C. · Class I
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- Blizzard — BLIZZARD PROTECTION SYSTEMS LIMITED · 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
- Safeguard Us Operating, Llc
Sources (1)
- FDA UDI cc37decf-f6a1-443f-ae5f-41f80becd7c7 34 fields · synced Jun 8, 2026