BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DEFENDO Air/Water/Suction and Biopsy Valve

    DI: 00677964055928 · Model: 100316 · MEDIVATORS INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DEFENDO Air/Water/Suction and Biopsy Valve
    Primary DI
    00677964055928
    Version / Model
    100316
    Company Name
    MEDIVATORS INC.
    Labeler DUNS
    068199363
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    6
    Public Version Date
    2022-04-27
    Public Version Status
    Update
    Public Device Record Key
    2b4c3564-a473-4acf-843e-4207a1eb87cf

    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
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ODC Endoscope Channel Accessory
    FDF Colonoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    60760 Endoscope channel support kit

    Identifiers

    Type ID
    Primary 00677964055928
    Package 20677964055922
    Package 10677964055925

    Premarket Submissions

    Submission Number Supplement Number
    K090851 000
    K102409 000
    K102581 000