Device
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 absorb...
Manufacturer
Rhythm Healthcare, LLC
Rhythm Healthcare, LLC
Model: LM5BA
Catalog: J5A
DI: 00850083102944
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c6700925-ddb6-4f31-840f-d39d3fa01e88
Distribution Status:
In Commercial Distribution
DUNS Number:
117783267
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850083102944
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 31321
Name: Mobile/portable oxygen concentrator
Definition:
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.
FDA Product Codes
CAW
Generator, Oxygen, Portable
Premarket Submissions
Submission Number:
K251607
Supplement Number:
000