BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BLOOD SET 170 MICRON, PUMP, NEEDLEFREE

    Reg #: 3004548776 · FEI: 3004548776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    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
    K830755

    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
    Set, Administration, Intravascular FPA

    Proprietary Names

    BLOOD SET 170 MICRON, PUMP, NEEDLEFREE 6 IN. EXTENSION, 0.2 MICRON AE FILTER EXTENSION, CHECK VALVE, 3GANG VALVES EXTENSION, 1.2 MICRON FILTER, SLIDE CLMP MICROBORE EXTENSION, 4-WAY STOPCOCK EXTENSION, 3GANG ASV, NEEDLEFREE VALVES 40 IN. EXTENSION SET, STOPCOCK EXTENSION, FLL, 0.2 MICRON FILTER BLOOD SET 170 MICRON FILTER NEEDLEFREE Y-BLOOD SET 170 MICRONFILTER NEEDLEFREE 3 IN. EXTENSION, 1.2 MICRON AE FILTER 3 IN. EXTEN, 1.2 MICRON AE FILTER 60 IN. MICROBORE, 0.2 MICRON FILTER LPV 4-WAY HI-FLOW STOPCOCK EXTENSION, 2GANG VALVES, Y-INJ SITE EXTENSION 0.2 MICRON FILTER, NEEDLEFREE BLOOD SET 170 MICRON, 2 NEEDLEFREE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198