BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PREMIER COMBO PLUS

    DI: 00816924020303 · Model: PREMCOMBOPLUSV2 · Tensproducts, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PREMIER COMBO PLUS
    Primary DI
    00816924020303
    Version / Model
    PREMCOMBOPLUSV2
    Catalog Number
    PREMCOMBOPLUSV2, PREMCOMBOPLUS-TP
    Company Name
    Tensproducts, LLC
    Labeler DUNS
    104307787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-21
    Public Version
    5
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    90b878f8-a3f0-4659-a090-e2704cdd7a3c

    Device Description

    TENS/EMS WITH 17 MODES AND AC ADAPTOR, 9 PRESETS

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    Package 10816924020300
    Package 00816924020426
    Primary 00816924020303
    Package 00816924020709

    Premarket Submissions

    Submission Number Supplement Number
    K071951 000