BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ROCKWELL MEDICAL

    Reg #: 1652176 · FEI: 3003463852 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROCKWELL MEDICAL
    Registration Number
    1652176
    FEI Number
    3003463852
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4051 Freeport Pkwy Ste 100
    City
    GRAPEVINE
    State
    TX
    ZIP
    76051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K954527

    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

    HEMODIALYSIS CONCENTRATE SOLUTIONS POWDERS Dri-Sate Acid Concentrate Mixes Bicarbonate Solution Concentrates for Bicarbonate Dialysis Citrapure Acid Concentrate NikkiCart

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198