Warmgel Infant Heel Warmer

FDA UDIEUDAMED

Class I (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: WARMGEL INFANT HEEL WARMER FDA UDI
Generic Name: Reactive-gel heating pad FDA UDI
Device Name: WarmGel INFANT HEEL WARMER FDA UDI
Model / Reference: 20418 FDA UDI
Description: WarmGel INFANT HEEL WARMER FDA UDI

Identifiers

Primary DI / UDI-DI: 20888937025716 FDA UDI
510(k) Number: K151845 FDA UDI
FDA Product Code: MPO 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 Infant Heel Warmer by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Reactive-gel heating pad.

Mibest — Beijing Choice Electronic Technology Co., Ltd. · Class II
Mibest — Beijing Choice Electronic Technology Co., Ltd. · Class II
PORTA-WARM — Cardinal Health 200, LLC · Class I
WARMGEL INSTANT HEAT PACK - Large — CooperSurgical, Inc. · Class I
Cooper Surgical INFANT HEEL WARMER — CooperSurgical, Inc. · Class I
fisherbrand Disposable Gel Infant Heel Warmer — CooperSurgical, Inc. · Class I
TRANSWARMER INFANT TRANSPORT MATTRESS — CooperSurgical, Inc. · Class I
fisherbrand Disposable Liquid Infant Heel Warmer — CooperSurgical, Inc. · Class I

Cleared under the same submission

K151845 also covers:

Cooper Surgical INFANT HEEL WARMER — CooperSurgical, Inc.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (2)

FDA UDI 60828319-4318-4d83-8a7c-84792a432638 34 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 18, 2026