FDA.reportPublic FDA data

Vive Breathe

Primary DI
00810226442917
Brand
Vive Breathe
Company
VIVE HEALTH LLC
Model
LVA3196CLR10PAK
Device description
CPAP Gel Nose Pads
Published
2026-10-12
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

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810226442917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810226442917008102264429178102264429170810226442917

GMDN Terms#

Term, Definition table
TermDefinition
Nasal breathing aid, externalAn external device intended to improve breathing by decreasing nasal resistance, thus increasing nasal airflow. The device typically consists of an adhesive bandage with two parallel elastic strips placed on the bridge of the nose; it acts with an upward pulling force to flare the nostrils and open the nares. It provides temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or nasal congestion. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226442870ViveSUP3192BLKS2026-10-12
00810226442887ViveSUP3192BLKM2026-10-12
00810226442894ViveSUP3192BLKL2026-10-12
00810226442900ViveSUP3192BLKXL2026-10-12
00810226442924ViveLVA1025PBU2026-10-12
00810226442931ViveLVA1025GBU2026-10-12
00810226442948ViveLVA1026PBU2026-10-12
00810226442955ViveLVA1026GBU2026-10-12
00810226442962ViveLVA3185BLKL2026-10-12
00810226440586ViveSUP3172BLKS2026-10-09
00810226442610ViveRHB3084RM2026-10-09
00810226442627ViveRHB3084RL2026-10-09
00810226442634ViveRHB3084LL2026-10-09
00810226442641ViveRHB3084LM2026-10-09
00810226442757ViveSUP3172BLKM2026-10-09
00810226442764ViveSUP3172BLKL2026-10-09
00810226442771ViveSUP3172BLKXL2026-10-09
00810178888900CoreTechSUP3137BLKXS2026-05-05
00810178888917CoreTechSUP3137BLKS2026-05-05
00810178888924CoreTechSUP3137BLKM2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689HHCWS01040Compact Wound Seal KitSafeguard US Operating, LLCNAE2026-10-13
M689TOCSEA030Curaplex TOCSSafeguard US Operating, LLCNAE2026-10-13
00743537001118BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00743537001224BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00743537001231BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-10-05
00841277111248Novera BalanceHarps USA, Inc.NAE2026-09-04
08809319802631HyFer HerNonMOON-X USA, Inc.NAE2026-08-03
00850083365011LaviorLavior Pharma Inc.NAE2026-07-17
00850083365028LaviorLavior Pharma Inc.NAE2026-07-17
06970206829191PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206829207PreviClear Border Sacrum Transparent Gel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-23
06970206820808kegel Hydrogel DressingJiangsu NewValue Medical Products Co.,Ltd.NAE2026-06-22
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22