BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BF-7

    DI: 00816625020060 · Model: TENS · Bio Medical Innovations
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BF-7
    Primary DI
    00816625020060
    Version / Model
    TENS
    Company Name
    Bio Medical Innovations
    Labeler DUNS
    173358318
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-03
    Public Version
    3
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    bd9ab22c-39f6-4335-aba1-1ed23e74f370

    Device Description

    1.25" X 2.25" Oval electrode patch in pouch of 4 each electrodes.

    Device Characteristics

    Single Use
    Yes
    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
    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 30816625020061
    Package 10816625020067
    Primary 00816625020060

    Customer Contacts

    Phone
    2082635071
    Email
    [email protected]