BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ShuntCheck Test Pack

    DI: 00865435000335 · Model: TP-1 · NEURODX DEVELOPMENT LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ShuntCheck Test Pack
    Primary DI
    00865435000335
    Version / Model
    TP-1
    Catalog Number
    TP-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
    a4e01a46-1994-4dd9-901b-31be87bf0ffc

    Device Description

    ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container

    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
    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 00865435000335
    Package 10865435000318

    Premarket Submissions

    Submission Number Supplement Number
    K123554 000