Rhythm Healthcare

GUDID 06971882890963

Qingdao Kingon Medical Science and Technology Co., Ltd

Mobile/portable oxygen concentrator

• Primary Device ID: 06971882890963
• NIH Device Record Key: 7a97c6e4-e896-4df3-adcf-1ed1212abeae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm Healthcare
• Version Model Number: TOC3
• 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	06971882890963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242718

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: 2025-03-17
• Device Publish Date: 2025-03-08

On-Brand Devices [Rhythm Healthcare]

• 06971882890635: P2-E
• 06971882890963: TOC3