FDA.reportPublic FDA data

VIVE

Primary DI
00818323028966
Brand
VIVE
Company
VIVE HEALTH LLC
Model
LVA2026
Device description
Water Flosser
Published
2019-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323028963PackageGS130In Commercial Distribution
00818323028966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302896310818323028963
00818323028966008183230289668183230289660818323028966

GMDN Terms#

Term, Definition table
TermDefinition
Water jet flosserAn electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.

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
00810226441002ViveLVA3171WHT2026-07-08
00818323025538ViveMOB1025BLU2019-03-07
00818323025545ViveMOB1025SLV2019-03-07
00810178887750Vive PrecisionDMD1097O28G2026-06-26
00810178887767Vive PrecisionDMD1097O30G2026-06-26
00810178889952ViveLVA3163BLK2026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950346764Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-07-08
00073950341295Waterpik Cordless Pearl Water FlosserWATER PIK, INC.EFS2026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-06-09
05060640673700OrdoORDOCLUB LTDEFS2026-05-29
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03