BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Roscoe Medical

    DI: 00092237615225 · Model: DQ7000 · COMPASS HEALTH BRANDS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Roscoe Medical
    Primary DI
    00092237615225
    Version / Model
    DQ7000
    Company Name
    COMPASS HEALTH BRANDS CORP.
    Labeler DUNS
    827221698
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    10
    Public Version Date
    2023-09-06
    Public Version Status
    Update
    Public Device Record Key
    c9b23558-4282-44b1-94da-d4d4a0e6293e

    Device Description

    InTENSity EX4 Professional

    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 50092237615220
    Primary 00092237615225

    Customer Contacts

    Phone
    800-376-7263
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K120217 000