BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISOPURE, CORP.

    Reg #: 3003768032 · FEI: 3013942511 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ISOPURE, CORP.
    Registration Number
    3003768032
    FEI Number
    3013942511
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    12500 Westport Rd., 12540 Westport Rd.
    City
    Louisville
    State
    KY
    ZIP
    40245
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993200

    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
    Subsystem, Water Purification FIP
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Tank, Holding, Dialysis FIN

    Proprietary Names

    MD420/440/460/470/480/490 Reverse O MD-100 Mobile Water Purification Sy Isopure ACDS (Acidified Concentrate Distribution and Storage) Isocube Aqua Caddy Isopure Complete Water System for H Isopure Sodium Bicarbonate Mixing and Distribution System Isopure Dry Acid Dissolution System Isopure Dry Acid Dissolution System, Acid Dissolution System, Accumix

    Establishment Types

    Manufacture Medical Device