BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Waters IGL Cold Storage Solution (CSS)

    Reg #: 2123774 · FEI: 2123774 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WATERS MEDICAL SYSTEMS, LLC
    Registration Number
    2123774
    FEI Number
    2123774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2900 37th St NW, Building 003
    City
    ROCHESTER
    State
    MN
    ZIP
    55901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221387

    Owner / Operator

    Firm Name
    Waters Medical Systems LLC
    Operator Number
    10024390
    Address
    2900 37th St NW, Building 003
    City
    Rochester
    State
    MN
    Postal Code
    55901
    Country
    US
    Correspondent
    Ashley Banks

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN
    Set, Perfusion, Kidney, Disposable KDL

    Proprietary Names

    Waters IGL Cold Storage Solution (CSS) BEL-GEN Cold Storage Solution

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198