FDA Registration
Active
🇺🇸 United States
Y-TYPE BLOOD COMPONENT RECIPIENT SET
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
- K073339
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, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2014-10-15 |
Proprietary Names
Y-TYPE BLOOD COMPONENT RECIPIENT SET
Blood Component Recipient Set
Blood Component Infusion Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility