FDA.reportPublic FDA data

VIVE

Primary DI
00810041981509
Brand
VIVE
Company
VIVE HEALTH LLC
Model
LVA2042
Device description
Nasal Rinse
Published
2020-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KARIrrigator, Sinus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KARIrrigator, SinusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041981506PackageGS11In Commercial Distribution
00810041981509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198150610810041981506
00810041981509008100419815098100419815090810041981509

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation saline solutionA water-based, salt solution (e.g., isotonic or hypertonic mineral-rich purified sea water) intended to penetrate, clear, clean, and sometimes hydrate the nasal passages and sinus cavity. The solution is typically self-administered (e.g., via a squeeze bottle, glass bottle with a mechanical spray pump, dropper or aerosol) for preventive or symptomatic nasal care. 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
00810226442719ViveMOB1168GRYLTH2026-10-20
00810226442726ViveMOB1168GRYAC2026-10-20
00810226443006ViveSUP3194ORG362026-10-20
00810226443013ViveSUP3195BLKSM2026-10-20
00810226443020ViveSUP3195BLKLXL2026-10-20
00810226442825ViveSUP3190BLKS2026-10-15
00810226442832ViveSUP3190BLKM2026-10-15
00810226442849ViveSUP3190BLKL2026-10-15
00810226442979Vive CareRHB3085PAK102026-10-14
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12
00810226442917Vive BreatheLVA3196CLR10PAK2026-10-12
00810226442924ViveLVA1025PBU2026-10-12
00810226442931ViveLVA1025GBU2026-10-12
00810226442948ViveLVA1026PBU2026-10-12
00810226442955ViveLVA1026GBU2026-10-12
00810226442962ViveLVA3185BLKL2026-10-12
00810226440586ViveSUP3172BLKS2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978785665117InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665124InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665148InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-12-08
06978785665056InhwRiorShenzhen Yuechuan trade Co., Ltd.KAR2025-08-08
00194613022020MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022044MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022051MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022068MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022075MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00194613022082MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-08-01
00805106849603XTREMEXtreme Personal Care Inc.KAR2025-04-20
00194613022006MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022013MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022037MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00194613022099MSI Precision Specialty InstrumentsMed Saver, Inc.KAR2025-03-21
00887482123874Symmetry ASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00887482124970Symmetry JacksonASPEN SURGICAL PRODUCTS, INC.KAR2024-08-15
00888515244573BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515244597BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251014BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251038BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251045BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251052BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251076BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251120BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251137BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251144BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251151BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
00888515251175BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAR2024-02-28
G586E97332590Novo SurgicalNOVO SURGICAL, INC.KAR2023-12-18