Identity
- Trade Name
- HELIOS System FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- Casualty hypothermia prevention and management system for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty. 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 for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty. 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-K FDA UDI
- Primary DI / UDI-DI
- 00818630010456 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
No
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
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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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- 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 |
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Manufacturer
- Manufacturer
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI ee4f0d52-f634-4e4c-b146-4c4dee00987d 34 fields · synced May 30, 2026