Rhythm Healthcare

GUDID 06971072050115

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.

Rhythm Healthcare, LLC

Mobile/portable oxygen concentrator

• Primary Device ID: 06971072050115
• NIH Device Record Key: b5990b57-a5ee-42a7-8a52-afdefbaeb708
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm Healthcare
• Version Model Number: LM5BA
• Company DUNS: 117783267
• Company Name: Rhythm Healthcare, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971072050115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102245

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-09-03

Devices Manufactured by Rhythm Healthcare, LLC

• 06971072050122 - Rhythm: 2025-02-13
• 06971072050115 - Rhythm Healthcare: 2024-09-11The 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.
• 06971072050115 - Rhythm Healthcare: 2024-09-11 The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation uni