BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BT2000 Automated Manifold Kit

    DI: 10841716100274 · Model: 014613 · ACIST MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BT2000 Automated Manifold Kit
    Primary DI
    10841716100274
    Version / Model
    014613
    Company Name
    ACIST MEDICAL SYSTEMS, INC.
    Labeler DUNS
    926684994
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-09
    Public Version
    4
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    fb3aeec1-7e75-4c9a-b97a-7f0989cc1815
    Distribution End Date
    2018-05-21

    Device Description

    Model BT2000 p/n 700287-012 Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    DXT Injector And Syringe, Angiographic

    GMDN Terms

    Code Name
    47258 Contrast medium injection system administration set

    Identifiers

    Type ID
    Package 30841716100278
    Primary 10841716100274