WARMGEL INSTANT HEAT PACK - Medium

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: WARMGEL INSTANT HEAT PACK - Medium FDA UDI
Generic Name: Activated-medium surgical warming blanket FDA UDI
Device Name: WARMGEL INSTANT HEAT PACK - Medium FDA UDI
Model / Reference: 20419 FDA UDI
Description: WARMGEL INSTANT HEAT PACK - Medium FDA UDI

Identifiers

Primary DI / UDI-DI: 20888937025723 FDA UDI
510(k) Number: K912715 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Activated-medium surgical warming blanket FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

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

FDA UDI

Category: Activated-medium surgical warming blanket

WARMGEL INSTANT HEAT PACK - Medium by CooperSurgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated-medium surgical warming blanket.

Infant Heel Warmer — INTERNATIONAL BIOMEDICAL, LTD. · Class I
Infant Heel Snuggler — INTERNATIONAL BIOMEDICAL, LTD. · Class I
FORWARD HEAT - Life Guard — INTEGRATED MEDCRAFT LLC · Class I
Barrier® EasyWarm® — Mölnlycke Health Care AB · Class II
FORWARD HEAT - Emergency Blanket — INTEGRATED MEDCRAFT LLC · Class I
NAR — NORTH AMERICAN RESCUE, LLC. · Class I
NAR — NORTH AMERICAN RESCUE, LLC.

Cleared under the same submission

K912715 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI e8188348-363f-4a15-976a-a5b8842d419b 34 fields · synced Jun 9, 2026