BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dario Smart Blood Pressure Monitor Gen 2

    DI: 00850033352061 · Model: 1217-05 · DARIOHEALTH CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dario Smart Blood Pressure Monitor Gen 2
    Primary DI
    00850033352061
    Version / Model
    1217-05
    Company Name
    DARIOHEALTH CORP.
    Labeler DUNS
    116902485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-27
    Public Version
    1
    Public Version Date
    2022-07-05
    Public Version Status
    New
    Public Device Record Key
    d5b3b03f-8e60-4558-90b9-f4351b0fe83b

    Device Description

    The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumference ranging from 8.75-16.5 inch (22-42 cm). It is intended for adult indoor use only.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Primary 00850033352061