AccessGUDID - DEVICE: AMPatch Stoma Cover (00838234001612)

GUDID

Device Identifier (DI) Information

Brand Name: AMPatch Stoma Cover
Version or Model: G-2 with Rectangular Hole
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Austin Medical Products, Inc.

Primary DI Number: 00838234001612
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 101403558 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58854	Absorbent stomal dressing	An absorbent protective covering/pad intended to be placed over a urinary or enteric stoma to protect it from harmful external influences, absorb and prevent the spread of sweat and stomal fluid/waste/leaks, and to protect the surrounding skin from irritation. It typically has a central hole and is typically 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, or attached around the connection between an ostomy base plate and an ostomy bag. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXE	Protector, Ostomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 55 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c1f6ed7-4e44-487c-b76e-8afa41a03660
Public Version Date: March 08, 2022
Public Version Number: 1
DI Record Publish Date: February 28, 2022