FDA Registration
Active
🇺🇸 United States
VM2000 Emergency and Transport Ventilator
Reg #: 3021607937
·
FEI: 3021607937
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Ventis Medical Inc
- Registration Number
- 3021607937
- FEI Number
- 3021607937
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 515 Executive Dr
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240807
Owner / Operator
- Firm Name
- Ventis Medical Inc.
- Operator Number
- 10091988
- Address
- 2 Stout Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
- Correspondent
- Karen Laub
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2024-11-22 |
Proprietary Names
VM2000 Emergency and Transport Ventilator
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device