BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SEPACELL R-500II LEUKOCYTE REDUCTION ADMINISTRATION SET FOR RED CELL TRANSFUSION

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K904223

    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
    Microfilter, Blood Transfusion CAK

    Proprietary Names

    SEPACELL R-500II LEUKOCYTE REDUCTION ADMINISTRATION SET FOR RED CELL TRANSFUSION SEPACELL LEUKOCYTE REDUCTION FILTER FOR RED CELLS

    Establishment Types

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