BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BD Blood Pump transfusion set

    DI: 00704411011852 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BD Blood Pump transfusion set
    Primary DI
    00704411011852
    Version / Model
    1
    Catalog Number
    AM-TS-000
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-12
    Public Version
    2
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    75c60092-99ac-4b75-97c9-e639b03ae6eb

    Device Description

    Blood Transfusion Set

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

    GMDN Terms

    Code Name
    38569 Blood transfusion set, non-exchange

    Identifiers

    Type ID
    Package 20704411011856
    Primary 00704411011852

    Premarket Submissions

    Submission Number Supplement Number
    K983559 000