BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike

    Reg #: 9612051 · FEI: 3002806457 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FENWAL INTERNATIONAL, INC.
    Registration Number
    9612051
    FEI Number
    3002806457
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C.
    City
    HAINA San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    BK230824

    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 - Functionally Closed Single Needle with PAS Spike AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike AMICUS Separator Amicus Apheresis Kit – Functionally Closed Single Needle with PAS Spike and Dual Plasma Containers Amicus Apheresis Kit – Functionally Closed Double Needle with PAS Spike and Dual Plasma Containers

    Establishment Types

    Manufacture Medical Device