BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Xenon Rebreathing System

    DI: 00718175001332 · Model: 060-133 · BIODEX MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Xenon Rebreathing System
    Primary DI
    00718175001332
    Version / Model
    060-133
    Catalog Number
    060-133
    Company Name
    BIODEX MEDICAL SYSTEMS, INC.
    Labeler DUNS
    043833813
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-18
    Public Version
    3
    Public Version Date
    2018-09-06
    Public Version Status
    Update
    Public Device Record Key
    1c9ac367-e563-499f-b044-794acc156f56

    Device Description

    Disposable Xenon-133 Rebreathing System

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYT System, Rebreathing, Radionuclide

    GMDN Terms

    Code Name
    40908 Xenon administration system, diagnostic nuclear medicine

    Identifiers

    Type ID
    Primary 00718175001332
    Package 30718175001364
    Package 10718175001346
    Package 20718175001350