BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System

    DI: 00850033352184 · Model: 1268-05 · DARIOHEALTH CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System
    Primary DI
    00850033352184
    Version / Model
    1268-05
    Company Name
    DARIOHEALTH CORP.
    Labeler DUNS
    116902485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-05
    Public Version
    1
    Public Version Date
    2026-01-13
    Public Version Status
    New
    Public Device Record Key
    43686a67-2fb7-42d9-856a-fe18b9d2367f

    Device Description

    The Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System is intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adults indoor use only.

    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
    MR Unsafe
    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 00850033352184