Rhythm ZY-10AB/115

GUDID 06971072050122

Rhythm Healthcare, LLC

Mobile/portable oxygen concentrator

• Primary Device ID: 06971072050122
• NIH Device Record Key: 1be0a6b9-da3d-483d-a6a1-43c2e330a810
• Commercial Distribution Discontinuation: 2030-02-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm
• Version Model Number: LM10A
• Catalog Number: ZY-10AB/115
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971072050122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240840

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: 2025-02-13
• Device Publish Date: 2025-02-05

Devices Manufactured by Rhythm Healthcare, LLC

• 06971072050122 - Rhythm: 2025-02-13
• 06971072050122 - Rhythm: 2025-02-13
• 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