Rhythm Healthcare, LLC

Primary DI
00850083102944
Brand
Rhythm Healthcare, LLC
Company
Rhythm Healthcare, LLC
Model
LM5BA
Catalog number
J5A
Device description
The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K251607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251607000Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd.2025-11-21CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083102944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083102944008500831029448500831029440850083102944

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
117783267
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083102319Rhythm HealthcareLM10AJ10A2026-04-22
00860014866548Rhythm Healthcare, LLCLM5BALM5BA2025-11-12
06978651650070RHYTHM HEALTHCARELM5BA2025-09-01
06971072050122RhythmLM10AZY-10AB/1152025-02-05
06971072050115Rhythm HealthcareLM5BA2024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
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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
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
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06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
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00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
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00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07