BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    1BYONE

    DI: 00858069007030 · Model: TMB-1585-BT · 1BYONEPRODUCTS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    1BYONE
    Primary DI
    00858069007030
    Version / Model
    TMB-1585-BT
    Company Name
    1BYONEPRODUCTS INC.
    Labeler DUNS
    845019202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-28
    Public Version
    5
    Public Version Date
    2020-06-05
    Public Version Status
    Update
    Public Device Record Key
    bdb584dd-ac80-40ce-8eab-82d6f280a683

    Device Description

    Wireless Arm Blood Pressure Monitor

    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
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    45618 Telemetric sphygmomanometer

    Identifiers

    Type ID
    Package 10858069007044
    Package 00858069007047
    Primary 00858069007030

    Premarket Submissions

    Submission Number Supplement Number
    K131395 000