FDA.reportPublic FDA data

AMPatch Stoma Cover

Primary DI
00838234000271
Brand
AMPatch Stoma Cover
Company
Austin Medical Products, Inc.
Model
AX with Oval Center 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 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.
Published
2021-05-18
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
00838234000271PrimaryGS10
00838234009991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00838234000271008382340002718382340002710838234000271
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
1-800-223-9310info@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
00838234001032AMPatch Stoma Cover"MPC with 7/8"" End 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075099115CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099122CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099139CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099146CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099153CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099160CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00810178887132ViveVIVE HEALTH LLCEXE2026-05-05
00810178887149ViveVIVE HEALTH LLCEXE2026-05-05
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
15056276805513EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819060EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819084EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097180CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097210AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097227AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00810113576992ViveCareVIVE HEALTH LLCEXE2025-05-13
00810113577098ViveCareVIVE HEALTH LLCEXE2024-09-04
00810113577135ViveCareVIVE HEALTH LLCEXE2024-09-04
00810113577159ViveCareVIVE HEALTH LLCEXE2024-09-04
00768455209484ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
00768455209514ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
00810113577142ViveCareVIVE HEALTH LLCEXE2024-07-12
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16