Rhythm Healthcare, LLC
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Basic Information
- Brand Name
- Rhythm Healthcare, LLC
- Primary DI
- 00860014866548
- Version / Model
- LM5BA
- Catalog Number
- LM5BA
- Company Name
- Rhythm Healthcare, LLC
- Labeler DUNS
- 117783267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-12
- Public Version
- 1
- Public Version Date
- 2025-11-20
- Public Version Status
- New
- Public Device Record Key
- e590cc27-8136-40de-9f1b-346bbd1f8cb7
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAW | Generator, Oxygen, Portable | Anesthesiology | 868.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31321 | Mobile/portable oxygen concentrator | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014866548 | GS1 |
Customer Contacts
- Phone
- 8139475334
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102245 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal