BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MediMax Tech

    DI: 00817325020701 · Model: Innostim Tens 2k Unit · MEDIMAX TECH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MediMax Tech
    Primary DI
    00817325020701
    Version / Model
    Innostim Tens 2k Unit
    Company Name
    MEDIMAX TECH INC.
    Labeler DUNS
    927071162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-02
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    4a2426de-6447-47e6-87d8-dfd24bfd587a

    Device Description

    Innostim Tens 2k Unit - Digital Tens Unit

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00817325020701
    Package 10817325020708
    Package 20817325020705

    Customer Contacts

    Phone
    855-633-4629
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K073438 000