BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Digital tens one channel

    DI: 04716770005607 · Model: BE-560 · BESMED HEALTH BUSINESS CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Digital tens one channel
    Primary DI
    04716770005607
    Version / Model
    BE-560
    Company Name
    BESMED HEALTH BUSINESS CORP.
    Labeler DUNS
    658023775
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    f523f01d-6a27-4a9f-b711-30960e548785

    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
    No
    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
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04716770005607

    Premarket Submissions

    Submission Number Supplement Number
    K031375 000