FDA Registration
Active
🇺🇸 United States
Volumat Line
Reg #: 3004548776
·
FEI: 3004548776
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FENWAL, INC.
- Registration Number
- 3004548776
- FEI Number
- 3004548776
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3 CORPORATE DR STE 300
- City
- LAKE ZURICH
- State
- IL
- ZIP
- 60047
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220301
Owner / Operator
- Firm Name
- Fresenius Kabi AG
- Operator Number
- 9027285
- Address
- Else-Kroner-Str. 1
- City
- 61352 Bad Homburg
- State
- DE-NOTA
- Postal Code
- NONE
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-12-10 |
Proprietary Names
Volumat Line
Establishment Types
Complaint File Establishment per 21 CFR 820.198