AMPatch Stoma Cover

GUDID 00838234009984

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 Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing Absorbent stomal dressing

• Primary Device ID: 00838234009984
• NIH Device Record Key: 761eba3c-0174-494a-b180-bcb5e0e7e83c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPatch Stoma Cover
• Version Model Number: MFFE with 1 1/2" Hole
• Company DUNS: 101403558
• Company Name: Austin Medical Products, Inc.
• Device Count: 30
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00838234004712 [Primary]
GS1	00838234004729 [Primary]
GS1	00838234005115 [Primary]
GS1	00838234005122 [Primary]
GS1	00838234005566 [Primary]
GS1	00838234005863 [Primary]
GS1	00838234009984 [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: 2022-12-08
• Device Publish Date: 2022-11-30

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