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 JACKET, L, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CUFFS, SILVER, 5 BG/CS NW FDA UDI
Model / Reference: 5140-400 FDA UDI
Description: THERMOFLECT JACKET, L, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CUFFS, SILVER, 5 BG/CS NW FDA UDI

Identifiers

Primary DI / UDI-DI: 30612899514400 FDA UDI
FDA Product Code: LYU FDA UDI
GMDN Term: Hypothermia-prevention whole-body suit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 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

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 d3129d34-732c-410f-9479-efee2a14fa0a 34 fields · synced May 30, 2026