Nova

FDA UDI

Class II (US FDA UDI)

by Encompass Group, L.L.C.

Identity

Trade Name: Nova FDA UDI
Generic Name: Hypothermia-prevention whole-body suit FDA UDI
Device Name: NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS FDA UDI
Model / Reference: AW5100-200 FDA UDI
Description: NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS FDA UDI

Identifiers

Primary DI / UDI-DI: 00612899006485 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

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

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Also classified as Hypothermia-prevention whole-body suit.

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Hypothermia Management Set - Bag (OR) and Grid (8 cell) — SAFEGUARD US OPERATING, LLC · Class I
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HELIOS System — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
HELIOS System — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
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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 44782433-e7a5-4bfc-bd87-c11ae64f9991 35 fields · synced May 30, 2026