FDA Registration
Active
🇺🇸 United States
NIDEK MEDICAL PRODUCTS, INC.
Reg #: 1039215
·
FEI: 1039215
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NIDEK MEDICAL PRODUCTS, INC.
- Registration Number
- 1039215
- FEI Number
- 1039215
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3949 VALLEY EAST INDUSTRIAL DR
- City
- Birmingham
- State
- AL
- ZIP
- 35217
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020797
Owner / Operator
- Firm Name
- NIDEK MEDICAL PRODUCTS, INC.
- Operator Number
- 1039215
- Address
- 3949 VALLEY EAST INDUSTRIAL DR, --
- City
- Birmingham
- State
- AL
- Postal Code
- 35217
- Country
- US
- Correspondent
- Olivia H Mullen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2018-05-17 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2007-11-12 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2007-11-12 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2010-03-08 |
Proprietary Names
Multi Flow (Freestanding)
Dual Flow (Remote Mounting)
Pulmo-Mist Compressor
Mark 5 Nuvo 8 OCSI (585, 985)
Mark 5 Nuvo 10 OCSI (595, 1005)
GCE Mediline Nuvo 8 (985GC, 985GCUK)
Mark 5 Nuvo 8 STD (580, 980)
Mark 5 Nuvo (505, 565, 905, 965)
New Aera Source 5 (565NA)
Nuvo Nano Portable Oxygen Concentrator
GCE Mediline Nuvo Lite (925GC)
Mark 5 Nuvo Lite OCSI (525, 925)
Mark 5 Nuvo Lite STD (520, 920)
Mark 5 Nuvo Lite 3 (935)
Max 30 Oxygen Concentrator
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only