Hypothermia Management Set - Bag (GR) and Grid (8 cell)

FDA UDI

Class I (US FDA UDI)

by Safeguard Us Operating, Llc

Identity

Trade Name: Hypothermia Management Set - Bag (GR) and Grid (8 cell) FDA UDI
Generic Name: Hypothermia-prevention whole-body suit FDA UDI
Device Name: This device is intended for use on adult patients who are at risk of developing or showing the signs and symptoms of hypothermia in the pre-hospital environment. WARNING: Do not place Ready-Heat on exposed skin. FDA UDI
Model / Reference: 01 FDA UDI
Description: This device is intended for use on adult patients who are at risk of developing or showing the signs and symptoms of hypothermia in the pre-hospital environment. WARNING: Do not place Ready-Heat on exposed skin. FDA UDI

Identifiers

Catalog Number: 59-110 FDA UDI
Primary DI / UDI-DI: M68959110010 FDA UDI
FDA Product Code: KME FDA UDI
IMD FDA UDI
GMDN Term: Hypothermia-prevention whole-body suit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6060 FDA UDI
890.5710 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

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hypothermia-prevention whole-body suit

Hypothermia Management Set - Bag (GR) and Grid (8 cell) by Safeguard Us Operating, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Safeguard Us Operating, Llc

Sources (1)

FDA UDI 2857527e-02e7-45dc-8952-8663827a5fc1 34 fields · synced Jun 6, 2026