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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PowerDot

    DI: 04719872330394 · Model: PD-01MR · ZMI ELECTRONICS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PowerDot
    Primary DI
    04719872330394
    Version / Model
    PD-01MR
    Catalog Number
    PD-01M
    Company Name
    ZMI ELECTRONICS LTD.
    Labeler DUNS
    657406062
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    976c174d-b79e-45d8-9e96-b827fe019325
    Distribution End Date
    2099-12-31

    Device Description

    PowerDot PD-01M Muscle Stimulator, Red (with PowerDot Mobile Application)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    17908 Physical therapy ultrasound/neuromuscular stimulation system

    Identifiers

    Type ID
    Primary 04719872330394
    Package 14719872330414
    Package 04719872330417