FDA Registration
Active
🇺🇸 United States
Optiflow
Reg #: 3017520736
·
FEI: 3017520736
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VENTEC LIFE SYSTEMS, INC.
- Registration Number
- 3017520736
- FEI Number
- 3017520736
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12350 NE Woodinville Drive, Building D, Suite A
- City
- Woodinville
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020332
Owner / Operator
- Firm Name
- REACT HEALTH
- Operator Number
- 10054872
- Address
- 5475 Rings Rd, Suite 550
- City
- Dublin
- State
- OH
- Postal Code
- 43017
- Country
- US
- Correspondent
- Tina Quintero
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2022-12-07 |
Proprietary Names
Optiflow
Establishment Types
Repack or Relabel Medical Device