FDA.reportPublic FDA data

ViveCare

Primary DI
00810113577142
Brand
ViveCare
Company
VIVE HEALTH LLC
Model
LVA3054CT10
Device description
Ostomy Adhesive Barrier (10PK)
Published
2024-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10810113577149PackageGS120In Commercial Distribution
00810113577142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357714910810113577149
00810113577142008101135771428101135771420810113577142

GMDN Terms#

Term, Definition table
TermDefinition
Skin surface device adhesiveA substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

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
00810178887156ViveVIVE 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
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16