FDA.reportPublic FDA data

Enteral

Primary DI
05060460843970
Brand
Enteral
Company
GBUK GROUP LIMITED
Model
EN-PLUG-S
Catalog number
EN-PLUG-S
Device description
Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm
Published
2022-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
false

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
05060460843987PackageGS1100In Commercial Distribution
05060460843970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060460843987050604608439875060460843987
05060460843970050604608439705060460843970

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal/urinary stoma buttonA plug-like device intended to be placed in an intestinal and/or urinary stoma to prevent leakage and narrowing (stenosis), typically during intermittent use of an enema catheter/tube. It is in the form of a flanged cylinder and is made of flexible synthetic polymer materials (e.g., silicone). This is a single-patient reusable device after appropriate cleaning/disinfection.

Regulatory Flags#

DUNS number
220705343
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002550006EnteralVED-691VED-6912022-11-01
10850002550013EnteralVED-692VED-6922022-11-01
10850002550020EnteralVED-693VED-6932022-11-01
10850002550037EnteralVED-694VED-6942022-11-01
10850801006995EnteralVED-690VED-6902022-11-01
00850801006967EnteralVED-670VED-6702022-10-20
05056038302895TenderTipTT02-05-E31TT02-05-E312023-06-02
05056038302925TenderTipTT02-06-E31TT02-06-E312023-06-02
05056038302956TenderTipTT02-06-P31TT02-06-P312023-06-02
05056038302987TenderTipTT02-07-P31TT02-07-P312023-06-02
05056038303014TenderTipTT02-08-E31TT02-08-E312023-06-02
05056038303045TenderTipTT02-08-P31TT02-08-P312023-06-02
05056038303083TenderTipTT02-10-E54-NTT02-10-E54-N2023-06-02
05056038303137TenderTipTT02-12-E54-NTT02-12-E54-N2023-06-02
05056038303175TenderTipTT02-12-T34-NTT02-12-T34-N2023-06-02
05056038303212TenderTipTT02-14-E54-NTT02-14-E54-N2023-06-02
05056038303250TenderTipTT02-14-T34-NTT02-14-T34-N2023-06-02
05056038303298TenderTipTT03-12-E54-NTT03-12-E54-N2023-06-02
05056038303335TenderTipTT03-12-T34-NTT03-12-T34-N2023-06-02
05056038303373TenderTipTT03-14-E54-NTT03-14-E54-N2023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
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15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097180CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
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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