BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Personal KinetiGraph (PKG)

    DI: 09359011000310 · Model: 2022-CHG-DOC-004 · GKC MANUFACTURING PTY LTD
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Personal KinetiGraph (PKG)
    Primary DI
    09359011000310
    Version / Model
    2022-CHG-DOC-004
    Company Name
    GKC MANUFACTURING PTY LTD
    Labeler DUNS
    742903370
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-20
    Public Version
    1
    Public Version Date
    2023-10-30
    Public Version Status
    New
    Public Device Record Key
    a0201a09-55e9-4e63-8ff8-b6eeee9da2d0

    Device Description

    The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.

    Device Characteristics

    Single Use
    No
    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
    Yes
    PM Exempt
    No
    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

    GMDN Terms

    Code Name
    61125 Neuromuscular motion disorder ambulatory recorder/analyser

    Identifiers

    Type ID
    Primary 09359011000310