FDA.reportPublic FDA data

ViveBreathe

Primary DI
00810178885770
Brand
ViveBreathe
Company
VIVE HEALTH LLC
Model
LVA3111ADP
Device description
Portable Oxygen Concentrator (AC Adapter)
Published
2026-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251130000Portable Oxygen Concentrator (JM-P50A)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.2025-08-21CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810178885770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810178885770008101788857708101788857700810178885770

GMDN Terms#

Term, Definition table
TermDefinition
Mobile/portable oxygen concentratorA mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818323026702ViveLVA1077PK482024-01-12
00818323026719ViveLVA1077PK722024-01-12
00810226441385ViveLVA3177BLK2026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970384252163SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360078HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360085HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360092HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
16970384252160SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
26970384252167SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360061HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-27
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953318MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953325MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953332MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953349MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
10840330700396ProcureTwin Med, LLCCAW2022-11-03