Identity
- Trade Name
- Nova FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- Nova Blanket, Lower Body Nova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS FDA UDI
- Model / Reference
- AW5100-300 FDA UDI
- Description
- Nova Blanket, Lower Body Nova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00612899006492 FDA UDI
- 510(k) Number
- K203085 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Hypothermia-prevention whole-body suit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hypothermia-prevention whole-body suit
Nova by Encompass Group, L.L.C. — Class II — 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
- Hypothermia Management Set - Bag (OR) and Grid (8 cell) — SAFEGUARD US OPERATING, LLC · Class I
- VYGON — Vygon Corp. · Class I
- Blizzard — BLIZZARD PROTECTION SYSTEMS LIMITED · Class I
- HELIOS System — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
- HELIOS System — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
- FORWARD APLS Thermal Guard Mylar — INTEGRATED MEDCRAFT LLC · Class I
- Hypothermia Management Set - Bag (GR) and Grid (8 cell) — SAFEGUARD US OPERATING, LLC · Class I
Cleared under the same submission
K203085 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Encompass Group, L.L.C.
Sources (1)
- FDA UDI 6f148201-9191-484a-9188-5d07bb642f0f 35 fields · synced Jun 8, 2026