BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dario Smart Scale (Cellular) - Weight Management System

    DI: 00850033352023 · Model: 1169-05 · DARIOHEALTH CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dario Smart Scale (Cellular) - Weight Management System
    Primary DI
    00850033352023
    Version / Model
    1169-05
    Company Name
    DARIOHEALTH CORP.
    Labeler DUNS
    116902485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-17
    Public Version
    3
    Public Version Date
    2022-06-28
    Public Version Status
    Update
    Public Device Record Key
    b714da12-7400-41ad-b746-6f6df03d85ed

    Device Description

    The Dario Smart Scale (Cellular) - Weight Management System is intended for measuring the body weight of adults and children (aged 10-17 years old). It is intended for 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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FRI Scale, Stand-On, Patient

    GMDN Terms

    Code Name
    38211 Stand-on floor scale, electronic

    Identifiers

    Type ID
    Primary 00850033352023