WARMGEL INSTANT HEAT PACK - Large

FDA UDI

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: WARMGEL INSTANT HEAT PACK - Large FDA UDI
Generic Name: Reactive-gel heating pad FDA UDI
Device Name: WARMGEL INSTANT HEAT PACK - Large FDA UDI
Model / Reference: 20420 FDA UDI
Description: WARMGEL INSTANT HEAT PACK - Large FDA UDI

Identifiers

Primary DI / UDI-DI: 20888937025730 FDA UDI
510(k) Number: K912715 FDA UDI
FDA Product Code: IMD FDA UDI
GMDN Term: Reactive-gel heating pad 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Reactive-gel heating pad

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

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Also classified as Reactive-gel heating pad.

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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

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI 567c6f1b-13c6-4ca2-814c-f0009e3d2237 34 fields · synced Jun 9, 2026