BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ShuntCheck III DAQ

    DI: 00865435000328 · Model: DAQ-1 · NEURODX DEVELOPMENT LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ShuntCheck III DAQ
    Primary DI
    00865435000328
    Version / Model
    DAQ-1
    Catalog Number
    DAQ-1
    Company Name
    NEURODX DEVELOPMENT LLC
    Labeler DUNS
    828682240
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-18
    Public Version
    1
    Public Version Date
    2018-11-19
    Public Version Status
    New
    Public Device Record Key
    a3c1db3c-0ac2-45b0-a439-b60963c08b1c

    Device Description

    Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor

    Device Characteristics

    Single Use
    No
    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
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JXG Shunt, Central Nervous System And Components

    GMDN Terms

    Code Name
    60309 Heater/cooler system tester kit

    Identifiers

    Type ID
    Primary 00865435000328

    Premarket Submissions

    Submission Number Supplement Number
    K123554 000