Vive

Primary DI
10810113577149
Brand
Vive
Company
VIVE HEALTH LLC
Model
LVA3054CT10
Device description
Ostomy Adhesive Barrier (10PK)
Published
2024-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EXEProtector, Ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810113577149PackageGS120In Commercial Distribution
00810113577142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357714910810113577149
00810113577142008101135771428101135771420810113577142

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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

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00810178887040ViveLVA1004DBLU2026-03-06
00810178887057ViveLVA2030DBLU2026-03-06
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00810178886906ViveSUP2019BGES2026-02-17
00810178886913ViveSUP2019BGEM2026-02-17
00810178886920ViveSUP2019BGEL2026-02-17
00810178886937ViveSUP2019BGEXL2026-02-17
00810178886944ViveSUP2019BLKXS2026-02-17
00810178886951ViveSUP2019BLKS2026-02-17
00810178886968ViveSUP2019BLKM2026-02-17

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10810113577156ViveCareVIVE HEALTH LLCEXE2024-09-04
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