RHYTHM HEALTHCARE
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Basic Information
- Brand Name
- RHYTHM HEALTHCARE
- Primary DI
- 06978651650070
- Version / Model
- LM5BA
- Company Name
- Rhythm Healthcare, LLC
- Labeler DUNS
- 117783267
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 2
- Public Version Date
- 2025-11-07
- Public Version Status
- Update
- Public Device Record Key
- caae72b5-e7e4-48c3-9e71-97f1d9848ae9
- Distribution End Date
- 2025-09-01
Device Description
The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation unit which is based on molecular sieves selective adsorption of nitrogen from air. It can continuously generate oxygen with the purity 93%±3% at ambient temperature. The adsorbed nitrogen can be desorbed by decreasing the adsorbed bed pressure resulting cyclical adsorption-desorption operation. The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it’s not intended to support or sustain life.
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 | 06978651650070 | GS1 | ||||
| Previous | 06971072050115 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102245 | 000 |