BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tens 7000 Conductive Glove

    DI: 00092237622100 · Model: DT7202-GLOVE · COMPASS HEALTH BRANDS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Tens 7000 Conductive Glove
    Primary DI
    00092237622100
    Version / Model
    DT7202-GLOVE
    Company Name
    COMPASS HEALTH BRANDS CORP.
    Labeler DUNS
    827221698
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2019-11-20
    Public Version
    4
    Public Version Date
    2023-09-12
    Public Version Status
    Update
    Public Device Record Key
    13b12ac4-9edc-425b-9b60-2bb73e6c1802

    Device Description

    Tens 7000 Conductive Glove includes (1) pair of gloves, snap lead wires, insert and pack of 3" round electrodes

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Package 80092237622021
    Primary 00092237622100
    Unit of Use 01092237622024

    Customer Contacts

    Phone
    800-376-7263
    Email
    [email protected]