AMPatch Stoma Cover

GUDID 00838234000813

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.

Austin Medical Products, Inc.

Absorbent stomal dressing

• Primary Device ID: 00838234000813
• NIH Device Record Key: 3f69da36-96d1-451d-a546-2f50d04ee2ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPatch Stoma Cover
• Version Model Number: G-3 with Rectangular Hole
• Company DUNS: 101403558
• Company Name: Austin Medical Products, Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com
• Phone: 800-223-9310
• Email: info@ampatch.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Storage Environment Temperature: Between 55 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00838234000813 [Primary]
GS1	00838234009991 [Unit of Use]

FDA Product Code

• EXE: Protector, Ostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-26
• Device Publish Date: 2021-05-18

On-Brand Devices [AMPatch Stoma Cover]

• 00838234009991: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to prot
• 00838234000813: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to prot
• 00838234009984: Absorbent stoma cover designed to be placed over a continent urinary or intestinal stoma to prot