FDA.reportPublic FDA data

AMPatch Stoma Cover

Primary DI
00838234001032
Brand
AMPatch Stoma Cover
Company
Austin Medical Products, Inc.
Model
"MPC with 7/8"" End Hole"
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 hole located on one end of the stoma cover, 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.
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXEProtector, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00838234001032PrimaryGS10
00838234009991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00838234001032008382340010328382340010320838234001032
00838234009991008382340099918382340099910838234009991

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent stomal dressingAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature55 Degrees Fahrenheit85 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-223-9310info@ampatch.com

Regulatory Flags#

DUNS number
101403558
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00838234000349AMPatch Stoma Cover"N-1 with 1 1/2"" Hole"2023-05-31
00838234000332AMPatch Stoma Cover"N-1 with 1 1/8"" Hole"2023-05-31
00838234000356AMPatch Stoma Cover"N-23 with 3/4"" Hole"2023-05-31
00838234000363AMPatch Stoma Cover"N-23 with 7/8"" Hole"2023-05-31
00838234000370AMPatch Stoma Cover"N-23 with 1"" Hole"2023-05-31
00838234000387AMPatch Stoma Cover"N-23 with 1 1/8"" Center Hole"2023-05-31
00838234000394AMPatch Stoma Cover"N-23 with 1 1/8"" Hole"2023-05-31
00838234000400AMPatch Stoma Cover"N-23 with 3/4"" Center Hole"2023-05-31
00838234000417AMPatch Stoma Cover"N-23 with 1 1/4"" Hole"2023-05-31
00838234000424AMPatch Stoma Cover"N-23 with 1 1/2"" Hole"2023-05-31
00838234001025AMPatch Stoma Cover"MPC with 7/8"" Center Hole"2023-05-31
00838234001049AMPatch Stoma Cover"MR with 7/8"" Hole"2023-05-31
00838234001056AMPatch Stoma Cover"MR with 1"" Hole"2023-05-31
00838234001063AMPatch Stoma Cover"MPX with 1 1/8"" Center Hole"2023-05-31
00838234001070AMPatch Stoma Cover"MPX with 1 1/8"" Hole"2023-05-31
00838234001681AMPatch Stoma Cover"N-1 with 1 1/4"" Hole"2023-05-31
00838234001865AMPatch Stoma Cover"MP with 1"" Hole"2023-05-31
00838234004705AMPatch Stoma Cover"MP with 1 1/4"" Hole"2023-05-31
00838234005993AMPatch Stoma CoverN-2 with Oval Hole2023-05-31
00838234001186AMPatch Stoma Cover"MP with 1 1/8"" Hole"2023-03-31

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