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Inogen One G4 System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IS-400
by Inogen, Inc.
Identity
- Trade Name
- Inogen One G4 System EUDAMEDInogen One G4 Oxygen Concentrator - Bluetooth FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Inogen Portable Oxygen Concentrators EUDAMEDInogen One G4 Oxygen Concentrator - Bluetooth (10-08300-00-01) FDA UDI
- Model / Reference
- IS-400 EUDAMED630 Bluetooth FDA UDI
- Description
- Inogen One G4 Oxygen Concentrator - Bluetooth (10-08300-00-01) FDA UDI
Identifiers
- Catalog Number
- IO-400 FDA UDI
- Primary DI / UDI-DI
- 00817131020179 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713102POCBU EUDAMED
- Direct Marketing DI
- 00817131020179 EUDAMED
- 510(k) Number
- K032818 FDA UDI
- 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
- France 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
No
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 One G4 System by Inogen, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081713102POCBU | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Inogen, Inc.
- EUDAMED SRN
- US-MF-000027368
- Authorised Representative
- Inogen Europe B.V. NL-AR-000033111
Sources (2)
- EUDAMED 3deee9b1-9220-4a24-9551-70a3814ad6bc 61 fields · synced Jul 26, 2026
- FDA UDI 3b692a43-f134-4343-96b3-408ea038b813 37 fields · synced May 30, 2026