GCB Medical Supply

FDA UDI

Class I (US FDA UDI)

by Gcb Medical Llc

Identity

Trade Name: GCB Medical Supply FDA UDI
Generic Name: Exothermic heat therapy pack/patch FDA UDI
Device Name: GCB MEDICAL WARMER HEEL INFANT 4IN X 4IN LATEX-FREE NON-STERILE SINGLE-USE FDA UDI
Model / Reference: GCBHW002 FDA UDI
Description: GCB MEDICAL WARMER HEEL INFANT 4IN X 4IN LATEX-FREE NON-STERILE SINGLE-USE FDA UDI

Identifiers

Catalog Number: GCBHW002 FDA UDI
Primary DI / UDI-DI: 00850061859228 FDA UDI
FDA Product Code: MPO FDA UDI
GMDN Term: Exothermic heat therapy pack/patch 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Exothermic heat therapy pack/patch

GCB Medical Supply by Gcb Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exothermic heat therapy pack/patch.

CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class I
TopCare health — Topco Associates, LLC · Class I
CozyTherm Heat Relief Patch, Neck — Dynarex Corp. · Class I
BackAid — Alva/Amco Pharmacal Companies, Inc. · Class I
BackAid — Alva/Amco Pharmacal Companies, Inc. · Class I
BackAid — Alva/Amco Pharmacal Companies, Inc. · Class I
Future Generation Medical — Global International L. L. C. · Class I
TopCare health — Topco Associates, 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

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

Manufacturer

Manufacturer: Gcb Medical Llc

Sources (1)

FDA UDI 750655d9-5198-4206-b8c7-1c9b412a2f33 35 fields · synced May 30, 2026