BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cell Wash/Infusion Bag; Thermogenesis Cell Wash/Infusion Bag

    Reg #: 3012821221 · FEI: 3012821221 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Global Life Sciences Solutions USA LLC
    Registration Number
    3012821221
    FEI Number
    3012821221
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    100 Results Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK980038

    Owner / Operator

    Firm Name
    Global Life Sciences Solutions USA LLC
    Operator Number
    1831947
    Address
    25 Harbor Park Drive
    City
    Port Washington
    State
    NY
    Postal Code
    11050
    Country
    US

    Products

    Device Name Product Code
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR

    Proprietary Names

    Cell Wash/Infusion Bag; Thermogenesis Cell Wash/Infusion Bag

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198