Identity
- Trade Name
- HELIOS System FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- Casualty hypothermia prevention and management system with active warming for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty with an active warming heat pack. Blanket anchors can be secured to most litters to reduce exposure from rotor wash and high winds. A high visibility pocket is located in the center for placement of STAT cards or other triage cards. Each blanket is 46" x 94". FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Casualty hypothermia prevention and management system with active warming for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty with an active warming heat pack. Blanket anchors can be secured to most litters to reduce exposure from rotor wash and high winds. A high visibility pocket is located in the center for placement of STAT cards or other triage cards. Each blanket is 46" x 94". FDA UDI
Identifiers
- Catalog Number
- HELIOS-KW FDA UDI
- Primary DI / UDI-DI
- 00818630010463 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Hypothermia-prevention whole-body suit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 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
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
No
FDA UDI
Category: Hypothermia-prevention whole-body suit
HELIOS System by Tactical Medical Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI 9b130695-188f-494a-a82d-8a8744c8c335 34 fields · synced Jun 8, 2026