Rhythm Healthcare

GUDID 06971882890635

Qingdao Kingon Medical Science and Technology Co., Ltd

Mobile/portable oxygen concentrator

• Primary Device ID: 06971882890635
• NIH Device Record Key: a63c8e7f-63f6-4317-9c55-8fa830df1837
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm Healthcare
• Version Model Number: P2-E
• Company DUNS: 554421353
• Company Name: Qingdao Kingon Medical Science and Technology Co., Ltd
• 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: true
• 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	06971882890635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223379

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: 2024-11-20
• Device Publish Date: 2024-11-12

Devices Manufactured by Qingdao Kingon Medical Science and Technology Co., Ltd

• 06971882890635 - Rhythm Healthcare: 2024-11-20
• 06971882890635 - Rhythm Healthcare: 2024-11-20
• 06971882890512 - Arya Airtivo MIN: 2024-06-12
• 06971882890291 - React: 2024-01-05
• 06971882890246 - Kingon: 2023-11-08
• 06971882890208 - Kingon: 2023-10-31
• 06971882890215 - Kingon: 2023-10-31
• 06971882890222 - Kingon: 2023-10-31
• 06971882890239 - Kingon: 2023-10-31