FDA.reportPublic FDA data

Eakin

Primary DI
15056276805513
Brand
Eakin
Company
T.G. EAKIN LIMITED
Model
839007
Device description
Eakin Freeseal Air 18mm ostomy barrier seal
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
15056276805513PrimaryGS10
05056276805516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505627680551315056276805513
05056276805516050562768055165056276805516

GMDN Terms#

Term, Definition table
TermDefinition
Peristomal/periwound dressingA non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
229282421
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15056276819060Eakin8390082026-02-03
15056276819084Eakin8390272026-02-03
15056276819091Eakin8390282026-02-03
05056276805516Eakin8390072026-02-03
05056276819063Eakin8390082026-02-03
05056276819087Eakin8390272026-02-03
05056276819094Eakin8390282026-02-03
00768455108725Eakin8390012023-05-16
00768455108732Eakin8390022023-05-16
00768455109333Eakin8390032023-05-16
00768455109340Eakin8390042023-05-16
00768455118250Eakin8390052023-05-16
00768455126798Eakin8392532023-05-16
00768455126804Eakin8392632023-05-16
00768455126811Eakin8392652023-05-16
00768455126828Eakin8392642023-05-16
00768455126835Eakin8392672023-05-16
00768455126842Eakin8392682023-05-16
00768455126859Eakin8392802023-05-16
00768455126866Eakin8392662023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178887132ViveVIVE HEALTH LLCEXE2026-05-05
00810178887149ViveVIVE HEALTH LLCEXE2026-05-05
00810178887156ViveVIVE HEALTH LLCEXE2026-05-05
00810178887163ViveVIVE HEALTH LLCEXE2026-05-05
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
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
00768455109333EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109340EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455118250EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455139170EakinT.G. EAKIN LIMITEDEXE2023-05-16
00610075092796CeraPlusHOLLISTER INCORPORATEDEXE2023-05-12