BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DRI-SATE MIXER

    Reg #: 1954315 · FEI: 3002970979 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCKWELL MEDICAL
    Registration Number
    1954315
    FEI Number
    3002970979
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    308 N Iowa Ave
    City
    WASHINGTON
    State
    IA
    ZIP
    52353
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022521

    Owner / Operator

    Firm Name
    Rockwell Medical
    Operator Number
    9030991
    Address
    30142 WIXOM RD., --
    City
    Wixom
    State
    MI
    Postal Code
    48393
    Country
    US

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    DRI-SATE MIXER BICARBONATE DIALYSATE CONCERTRATE

    Establishment Types

    Manufacture Medical Device