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
00810178883127ViveSUP3108S2026-07-21
00810178883134ViveSUP3108M2026-07-21
00810178883141ViveSUP3108L2026-07-21
00810178883158ViveSUP3108XL2026-07-21
00810226441217ViveLVA3173WOOD2026-07-21
00810226441224SuresLVA3174BFL2026-07-21
00810226441231SuresLVA3174BLK2026-07-21
00810226441248SuresLVA3174RPF2026-07-21
00810178889334SuresLVA2040NAV2026-07-17
00810178889341SuresLVA2040NAV2PAK2026-07-17
00810178889358SuresLVA2040NAV4PAK2026-07-17
00810226441156SuresLVA2040BLK2026-07-17
00810226441163SuresLVA2040BLK2PAK2026-07-17
00810226441170SuresLVA2040BLK4PAK2026-07-17
00810226441187SuresLVA2040TAN2026-07-17
00810226441194SuresLVA2040TAN2PAK2026-07-17
00810226441200SuresLVA2040TAN4PAK2026-07-17
00810226440593CoreTechSUP31702026-07-16
00818323020014ViveLVA10412026-07-16
00810226440623ViveSUP3168BGES2026-07-14

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