← Back to catalogue
Inogen Rove 6
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref IS-501
by Inogen, Inc.
Identity
- Trade Name
- Inogen Rove 6 EUDAMEDFDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Inogen Portable Oxygen Concentrators EUDAMED2.1. 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
- IS-501 EUDAMED10-12017-00-02 (BT) FDA UDI
- Description
- 2.1. 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
- Catalog Number
- IO-501 FDA UDI
- Primary DI / UDI-DI
- 00817131020513 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713102POCBU EUDAMED
- Direct Marketing DI
- 00817131020513 EUDAMED
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Inogen Rove 6 by Inogen, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230052 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 081713102POCBU | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inogen, Inc.
- EUDAMED SRN
- US-MF-000027368
- Authorised Representative
- Inogen Europe B.V. NL-AR-000033111
Sources (3)
- EUDAMED ae1bcdf7-9972-47d8-b75d-508cb0ec9eb8 61 fields · synced Jun 18, 2026
- FDA UDI eb5936a8-33ab-4806-ad18-46c23440f16f 36 fields · synced May 26, 2026
- FDA 510(k) K230052 1 fields · synced May 18, 2026