Identity
- Trade Name
- HAWK w/Carrier Set FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- HAWK Advanced Hypothermia Management Set with Carrier Set 1 ea - 23" x 20" HAWK Waring Grid with absorbent pad, 1 ea - 32" x 81" Thermal Patient Litter System Warning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- HAWK Advanced Hypothermia Management Set with Carrier Set 1 ea - 23" x 20" HAWK Waring Grid with absorbent pad, 1 ea - 32" x 81" Thermal Patient Litter System Warning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use. FDA UDI
Identifiers
- Catalog Number
- 83-315-01 FDA UDI
- Primary DI / UDI-DI
- M6898331501010 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
- 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
Category: Hypothermia-prevention whole-body suit
HAWK w/Carrier Set by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypothermia-prevention whole-body suit.
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- Thermoflect — Encompass Group, L.L.C. · 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
- Thermoflect — Encompass Group, L.L.C. · Class I
- VYGON — Vygon Corp. · Class I
- 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 262f150e-b47e-4ddc-ada8-b4b6b7754e18 34 fields · synced May 29, 2026