BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterile Bulb & Bladder

    DI: 10848956006175 · Model: SBB-01-5 · HEALTHMARK INDUSTRIES CO., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5

    Basic Information

    Brand Name
    Sterile Bulb & Bladder
    Primary DI
    10848956006175
    Version / Model
    SBB-01-5
    Company Name
    HEALTHMARK INDUSTRIES CO., INC.
    Labeler DUNS
    057680480
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2023-08-25
    Public Version
    1
    Public Version Date
    2023-09-04
    Public Version Status
    New
    Public Device Record Key
    659e7203-f90e-402d-908f-72ff5b6e2c39

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FCY Bulb, Inflation, For Endoscope

    GMDN Terms

    Code Name
    35800 Endoscope inflation bulb

    Identifiers

    Type ID
    Unit of Use 00848956006178
    Primary 10848956006175