FDA Registration
Active
🇺🇸 United States
AMICUS SEPARATOR SYSTEM
Reg #: 3004548776
·
FEI: 3004548776
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
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
- BK110030
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 |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2014-10-16 |
Proprietary Names
AMICUS SEPARATOR SYSTEM
4R4580 - AMICUS SEPARATOR
4R4580R - AMICUS SEPARATOR, REFURBISHED
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility