BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioMedical Life Systems,

    DI: 08908008085284 · Model: Bio Med Fit · JOHARI DIGITAL HEALTHCARE LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioMedical Life Systems,
    Primary DI
    08908008085284
    Version / Model
    Bio Med Fit
    Company Name
    JOHARI DIGITAL HEALTHCARE LIMITED
    Labeler DUNS
    675938472
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-09
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    583213a7-a289-48d1-a805-dec1993bbb32

    Device Description

    Physiotherapy Equipment

    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
    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
    Primary 08908008085284

    Premarket Submissions

    Submission Number Supplement Number
    K060246 000