BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isopure Sodium Bicarbonate Mixing and Distribution System

    Reg #: 3003768032 · FEI: 3013942511 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOPURE, CORP.
    Registration Number
    3003768032
    FEI Number
    3013942511
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12500 Westport Rd., 12540 Westport Rd.
    City
    Louisville
    State
    KY
    ZIP
    40245
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112427

    Owner / Operator

    Firm Name
    ISOPURE CORP.
    Operator Number
    9042051
    Address
    11851 Plantside Drive, --
    City
    Louisville
    State
    KY
    Postal Code
    40299
    Country
    US
    Correspondent
    KEVIN C GILLESPIE

    Products

    Device Name Product Code
    Tank, Holding, Dialysis FIN

    Proprietary Names

    Isopure Sodium Bicarbonate Mixing and Distribution System

    Establishment Types

    Manufacture Medical Device