FDA Registration
Active
🇺🇸 United States
Nuwellis, Inc.
Reg #: 3007137787
·
FEI: 3007137787
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Nuwellis, Inc.
- Registration Number
- 3007137787
- FEI Number
- 3007137787
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12988 Valley View Rd
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233515
Owner / Operator
- Firm Name
- Nuwellis, Inc.
- Operator Number
- 10026935
- Address
- 12988 Valley View Road
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Dawn Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2024-01-10 |
| Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use | NQJ | Class 2 | Gastroenterology, Urology | No | 2024-01-10 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2024-01-10 |
| Midline Catheter | PND | Class 2 | General Hospital | No | 2024-01-10 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2024-01-10 |
Establishment Types
Manufacture Medical Device