Thermoflect

FDA UDI

Class I (US FDA UDI)

by Encompass Group, L.L.C.

Identity

Trade Name: Thermoflect FDA UDI
Generic Name: Hypothermia-prevention whole-body suit FDA UDI
Device Name: THERMOFLECT GOWN KIT A, 25 EA TS THERMOFLECT GOWN KIT A, GOWN, CAP, PSFW,1 BEL BG, 25EA NW FDA UDI
Model / Reference: 5000-800 FDA UDI
Description: THERMOFLECT GOWN KIT A, 25 EA TS THERMOFLECT GOWN KIT A, GOWN, CAP, PSFW,1 BEL BG, 25EA NW FDA UDI

Identifiers

Primary DI / UDI-DI: 00612899004108 FDA UDI
FDA Product Code: FME FDA UDI
GMDN Term: Hypothermia-prevention whole-body suit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6265 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Thermoflect by Encompass Group, L.L.C. — 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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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

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: Encompass Group, L.L.C.

Sources (1)

FDA UDI 4fb0cfe8-f54e-4c0a-9dec-53abad86dd7c 34 fields · synced May 30, 2026