BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick

    DI: 00016958058437 · Model: Switch-It · SUNRISE MEDICAL (US) LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CTRL+5, Dual Pro, Joystick in a Can, MicroGuide, MicroPilot, and Tough JoyStick
    Primary DI
    00016958058437
    Version / Model
    Switch-It
    Catalog Number
    SWI
    Company Name
    SUNRISE MEDICAL (US) LLC
    Labeler DUNS
    962525056
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-12
    Public Version
    1
    Public Version Date
    2021-05-20
    Public Version Status
    New
    Public Device Record Key
    e04081e8-7f3c-4e40-a754-4fb97ac55cfc

    Device Description

    Alternative drive controls for users who cannot use standard power wheelchair controls.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNN Components, Wheelchair

    GMDN Terms

    Code Name
    30018 Wheelchair steering/control unit

    Identifiers

    Type ID
    Primary 00016958058437