Rhythm Healthcare, LLC

Primary DI
00860014866548
Brand
Rhythm Healthcare, LLC
Company
Rhythm Healthcare, LLC
Model
LM5BA
Catalog number
LM5BA
Device description
The Rhythm Healthcare LM5BA is a stationary (home-use) continuous-flow oxygen concentrator designed to provide supplemental oxygen therapy in residential, nursing home or other non-acute care settings. The device uses the pressure swing adsorption (PSA) principle to separate oxygen from ambient air via molecular sieve beds. The LM5BA delivers oxygen at a continuous flow rate of up to 5 liters per minute, with an output oxygen concentration of approximately 93% ± 3% under rated conditions. The device is intended for use by adult, geriatric, and pediatric patients under the prescription and supervision of a qualified physician. It is not intended to sustain or support life in the sense of life-support systems. Key features include a user-friendly control panel, audible and visual alarms for temperature, oxygen purity, high/low pressure, power failure and blockage, low noise operation, high output pressure design, and optional accessories such as a transfill rack. Typical specifications:• Flow rate: up to 5
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K102245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102245000CARE ZY5BA OXYGEN CONCENTRATORFoshan Care Medical Technology Co., Ltd.2010-11-09CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014866548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014866548008600148665488600148665480860014866548

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure-40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8139475334uunderwood@rhythmhc.com

Regulatory Flags#

DUNS number
117783267
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083102944Rhythm Healthcare, LLCLM5BAJ5A2026-04-24
00850083102319Rhythm HealthcareLM10AJ10A2026-04-22
06978651650070RHYTHM HEALTHCARELM5BA2025-09-01
06971072050122RhythmLM10AZY-10AB/1152025-02-05
06971072050115Rhythm HealthcareLM5BA2024-09-03

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