BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RENPHO Automatic Blood Pressure Monitor

    DI: 00810140060990 · Model: R-J004 · Joicom Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RENPHO Automatic Blood Pressure Monitor
    Primary DI
    00810140060990
    Version / Model
    R-J004
    Company Name
    Joicom Corporation
    Labeler DUNS
    033774836
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-08
    Public Version
    1
    Public Version Date
    2023-08-16
    Public Version Status
    New
    Public Device Record Key
    717c77c6-bed4-414b-890f-a39335b3c04f

    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
    Yes
    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
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Package 10810140060997
    Primary 00810140060990

    Premarket Submissions

    Submission Number Supplement Number
    K120058 000