YUWELL Oxygen Concentrator

GUDID 16933257921853

This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.

Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.

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• Primary Device ID: 16933257921853
• NIH Device Record Key: 279d274f-ac60-4645-a06a-20252f51c869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YUWELL Oxygen Concentrator
• Version Model Number: 8F-5A
• Company DUNS: 528704000
• Company Name: Jiangsu Yuyue Medical Equipment & Supply 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: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933257921856 [Primary]
GS1	16933257921853 [Package]; Contains: 06933257921856; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213825

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-01-09

On-Brand Devices [YUWELL Oxygen Concentrator]

• 16933257921853: This oxygen concentrator is intended for individual use as an oxygen supplement device in the pr
• 06933257921849: This oxygen concentrator is intended for individual use as an oxygen supplement device in the pr