BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASiR-V

    DI: 00840682134972 · Model: 1.0 · GE HEALTHCARE JAPAN CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ASiR-V
    Primary DI
    00840682134972
    Version / Model
    1.0
    Company Name
    GE HEALTHCARE JAPAN CORPORATION
    Labeler DUNS
    696021596
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-25
    Public Version
    4
    Public Version Date
    2020-08-18
    Public Version Status
    Update
    Public Device Record Key
    5ff9c93b-0271-4b32-b9f0-403b83e936ff

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAK System, x-ray, tomography, computed

    GMDN Terms

    Code Name
    40867 CT system application software

    Identifiers

    Type ID
    Primary 00840682134972

    Premarket Submissions

    Submission Number Supplement Number
    K132410 000
    K133640 000