FDA Registration
Active
🇺🇸 United States
VIXONE
Reg #: 2028807
·
FEI: 1000374126
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- WESTMED, INC.
- Registration Number
- 2028807
- FEI Number
- 1000374126
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5580 S NOGALES HWY
- City
- TUCSON
- State
- AZ
- ZIP
- 85706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K800562
Owner / Operator
- Firm Name
- WESTMED, INC.
- Operator Number
- 9006543
- Address
- 5580 S. NOGALES HIGHWAY, --
- City
- Tucson
- State
- AZ
- Postal Code
- 85706
- Country
- US
- Correspondent
- Peter Tountas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 1992-12-11 |
Proprietary Names
VIXONE
VIXTWO(HIFLO)
INFANT NEB
FAN JET
PEDI NEB
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility