BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bicarbonate Solution Concentrates for Bicarbonate Dialysis

    Reg #: 1835498 · FEI: 3001236991 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROCKWELL MEDICAL
    Registration Number
    1835498
    FEI Number
    3001236991
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30142 WIXOM RD.
    City
    WIXOM
    State
    MI
    ZIP
    48393
    Country
    US

    Regulatory Submissions

    510(k) Number
    K971053

    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

    Bicarbonate Solution Concentrates for Bicarbonate Dialysis

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device