Identity
- Trade Name
- Inogen FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Voxi 5 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06933257935419 FDA UDI
- 510(k) Number
- K213825 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Stationary oxygen concentrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Stationary oxygen concentrator
Inogen by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary oxygen concentrator.
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- OxyHome — Mv Life LLC · Class II
- NewLife Intensity 10 — CAIRE INC. · Class II
- konsung — Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. · Class II
- NewLife Intensity — Airsep Corp. · Class II
- DeVilbiss — DeVilbiss Healthcare LLC. · Class II
- Oxygen Concentrator — Proactive Medical Products · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Sources (1)
- FDA UDI 67b14f3f-80d2-4d64-8ba0-3860071efa1f 34 fields · synced May 31, 2026