BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Takeda Pharmaceuticals U.S.A., Inc.

    Reg #: 3016938816 · FEI: 3016938816 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Registration Number
    3016938816
    FEI Number
    3016938816
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    95 Hayden Avenue
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092318

    Owner / Operator

    Firm Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Operator Number
    10079762
    Address
    500 Kendall St.
    City
    Cambridge
    State
    MA
    Postal Code
    02142
    Country
    US
    Correspondent
    Shilpa Gampa

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI
    Set, Administration, Intravascular FPA
    Control, Plasma, Abnormal GGC

    Proprietary Names

    Baxject II Hi-Flow Needleless Transfer Device Baxject II Needleless Transfer Device FlowEase Subcutaneous Infusion Set Obizur Recombinant Factor VIII Substrate Cinryze

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility