AMPatch Stoma Cover

FDA UDI

Class I (US FDA UDI)

by Austin Medical Products, Inc.

Identity

Trade Name: AMPatch Stoma Cover FDA UDI
Generic Name: Absorbent stomal dressing FDA UDI
Device Name: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device. FDA UDI
Model / Reference: GB with 1" Hole FDA UDI
Description: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to protect it, absorb and prevent the spread of mucosal secretions, and to protect the surrounding skin from irritation. It has a central hole, and is attached by the patient directly over the stomal opening and held in place by its pressure-sensitive adhesive (e.g., polyacrylate or silicone) to the surrounding skin. This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI: 00838234000448 FDA UDI
FDA Product Code: EXE FDA UDI
GMDN Term: Absorbent stomal dressing FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5900 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

Yes

FDA UDI

Convenience Kit

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Absorbent stomal dressing

AMPatch Stoma Cover by Austin Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Absorbent stomal dressing.

Mestopore® — Mölnlycke Health Care AB · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · Class I
AMPatch Stoma Cover — AUSTIN MEDICAL PRODUCTS, INC. · 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

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Manufacturer

Manufacturer: Austin Medical Products, Inc.

Sources (1)

FDA UDI 43fb94dc-ab0f-4781-a811-48d90f19bb3a 35 fields · synced May 31, 2026