BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amicus Apheresis Kit Double Needle Functionally Closed Kit

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    BK160112

    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
    Separator, Automated, Blood Cell, Diagnostic GKT

    Proprietary Names

    Amicus Apheresis Kit Double Needle Functionally Closed Kit Platelet Storage Container Amicus Apheresis Kit Double Needle MNC Kit Amicus Apheresis Kit Single Needle Advanced Kit Amicus Apheresis Kit Single Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Single Needle Closed Kit Amicus Apheresis Kit Double Needle Closed Kit Amicus Apheresis Kit Double Needle Advanced Kit Amicus Apheresis Kit Double Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Single Needle Functionally Closed Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility