BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precision TENS3900

    DI: 00850209007016 · Model: TENS3900V2-MFR · MEDICAL FINANCE RESOURCES INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Precision TENS3900
    Primary DI
    00850209007016
    Version / Model
    TENS3900V2-MFR
    Catalog Number
    TENS3900V2-MFR
    Company Name
    MEDICAL FINANCE RESOURCES INC
    Labeler DUNS
    938569712
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-21
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    c15c6727-c3b0-42ad-9512-adeef849c6b4

    Device Description

    PRECISION TENS3900 4 MODE 90mA ANALOG TENS UNIT WITH TIMER

    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 10850209007013
    Package 00850209007023
    Primary 00850209007016

    Premarket Submissions

    Submission Number Supplement Number
    K003487 000