Identity
- Trade Name
- Oxygo Next Rove 6 FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- The OxyGo Next - (Rove 6) is a white label version of the Inogen Rove 6™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 6™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments. FDA UDI
- Model / Reference
- OxyGo Next Rove 6 (10-13402-00-01) FDA UDI
- Description
- The OxyGo Next - (Rove 6) is a white label version of the Inogen Rove 6™ Portable Oxygen Concentrator system is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen Rove 6™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817131020704 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Mobile/portable 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mobile/portable oxygen concentrator
Oxygo Next Rove 6 by Inogen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Inogen, Inc.
Sources (1)
- FDA UDI be053b5a-a265-4322-9594-021efe6fbaf6 35 fields · synced Jun 8, 2026