Inogen

GUDID 06933257935419

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

JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

Stationary oxygen concentrator

• Primary Device ID: 06933257935419
• NIH Device Record Key: 67b14f3f-80d2-4d64-8ba0-3860071efa1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inogen
• Version Model Number: Voxi 5
• 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	06933257935419 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-19
• Device Publish Date: 2025-06-11

Devices Manufactured by JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.

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