BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Recombinant Factor VIII Substrate, Porcine Sequence

    DI: 00198815000107 · Model: 6521753 · Takeda Pharmaceuticals U.S.A., Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Recombinant Factor VIII Substrate, Porcine Sequence
    Primary DI
    00198815000107
    Version / Model
    6521753
    Catalog Number
    6521753
    Company Name
    Takeda Pharmaceuticals U.S.A., Inc.
    Labeler DUNS
    041877817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-01
    Public Version
    1
    Public Version Date
    2025-08-11
    Public Version Status
    New
    Public Device Record Key
    2068ec62-b067-458a-a1d7-b6f7d10474e0

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GGC Control, Plasma, Abnormal

    GMDN Terms

    Code Name
    64895 Coagulation factor VIII IVD, antibody

    Identifiers

    Type ID
    Primary 00198815000107

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    36 – 46 Degrees Fahrenheit