BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Bivona

    DI: 10351688804341 · Model: XT11KS70NNC062N · SMITHS MEDICAL ASD, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bivona
    Primary DI
    10351688804341
    Version / Model
    XT11KS70NNC062N
    Company Name
    SMITHS MEDICAL ASD, INC.
    Labeler DUNS
    118112924
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-08-31
    Public Version
    6
    Public Version Date
    2020-09-11
    Public Version Status
    Update
    Public Device Record Key
    f32c5f1f-b882-4ca5-acbe-fb9ef1596665
    Distribution End Date
    2020-09-11

    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
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    JOH Tube tracheostomy and tube cuff

    GMDN Terms

    Code Name
    38792 Tracheostomy tube, non-reinforced, non-customized, reusable

    Identifiers

    Type ID
    Primary 10351688804341

    Premarket Submissions

    Submission Number Supplement Number
    K923878 000