FDA Registration
Active
🇺🇸 United States
INOGEN, INC.
Reg #: 3004672275
·
FEI: 3004672275
·
Expires 2026
Products
4
Proprietary Names
17
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- INOGEN, INC.
- Registration Number
- 3004672275
- FEI Number
- 3004672275
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 859 Ward Drive, Suite 200
- City
- Goleta
- State
- CA
- ZIP
- 93111
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203347
Owner / Operator
- Firm Name
- INOGEN, INC.
- Operator Number
- 9064201
- Address
- 859 Ward Drive, Suite 200
- City
- Goleta
- State
- CA
- Postal Code
- 93111
- Country
- US
- Correspondent
- Elias Cury
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2025-06-18 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2023-03-20 |
| Mechanical Ventilator | ONZ | Class 2 | Anesthesiology | No | 2019-08-16 |
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | Class 2 | Anesthesiology | No | 2025-03-06 |
Proprietary Names
Aurora
Inogen Rove 4 Portable Oxygen Concentrator
INOGEN ONE G3 OXYGEN CONCENTRATOR
OxyGo Fit
INOGEN ONE G4 OXYGEN CONCENTRATOR
INOGEN ONE OXYGEN CONCENTRATOR
INOGEN ONE G5 OXYGEN CONCENTRATOR
INOGEN ONE G4 BLUETOOTH OXYGEN CONCENTRATOR
OxyGo
OxyGo NEXT
OxyGo Fit BLUETOOTH
INOGEN ONE G2 OXYGEN CONCENTRATOR
TAV System
Inogen Rove 6 Portable Oxygen Concentrator
Voxi 5
Inogen At Home GS 100 Oxygen Concentrator
SIMEOX 200 Airway Clearance Device
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device