FDA Registration
Active
🇺🇸 United States
Vapotherm Inc.
Reg #: 3012971441
·
FEI: 3012971441
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- Vapotherm Inc.
- Registration Number
- 3012971441
- FEI Number
- 3012971441
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 100 Domain Dr
- City
- Exeter
- State
- NH
- ZIP
- 03833
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN170001
Owner / Operator
- Firm Name
- VAPOTHERM, INC.
- Operator Number
- 9038880
- Address
- 100 Domain Drive, --
- City
- Exeter
- State
- NH
- Postal Code
- 03833
- Country
- US
- Correspondent
- Neeraj Pardhy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2018-12-11 |
| High Flow/High Velocity Humidified Oxygen Delivery Device | QAV | Class 2 | Anesthesiology | No | 2019-01-18 |
| Bottle, Collection, Breathing System (Calibrated) | CBD | Class 2 | General Hospital | No | 2020-08-04 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2021-11-15 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2023-02-21 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2018-12-11 |
Proprietary Names
ProSoft Nasal Cannula
FELIX-1
HVT 2
PF-ADPC-LOW
AAA-2
Vapotherm Transfer Unit
Precision Flow Heliox
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device