BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIOFLUX

    DI: B635BIOFLUX100 · Model: 1.0 · BIOTRICITY INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    6
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIOFLUX
    Primary DI
    B635BIOFLUX100
    Version / Model
    1.0
    Company Name
    BIOTRICITY INC
    Labeler DUNS
    023227352
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-02
    Public Version
    3
    Public Version Date
    2019-05-07
    Public Version Status
    Update
    Public Device Record Key
    4e902b39-b065-4703-92cf-59861d26300a

    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

    GMDN Terms

    Code Name
    36367 Electrocardiography telemetric monitoring system transmitter

    Identifiers

    Type ID
    Package B635BIOFLUX101
    Primary B635BIOFLUX100
    Package B635BIOFLUX105
    Package B635BIOFLUX104
    Package B635BIOFLUX103
    Package B635BIOFLUX102

    Premarket Submissions

    Submission Number Supplement Number
    K172311 000