BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SMARTHEART

    DI: 00845717009379 · Model: 01-521 · VERIDIAN HEALTHCARE LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SMARTHEART
    Primary DI
    00845717009379
    Version / Model
    01-521
    Company Name
    VERIDIAN HEALTHCARE LLC
    Labeler DUNS
    830437997
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-13
    Public Version
    4
    Public Version Date
    2022-08-24
    Public Version Status
    Update
    Public Device Record Key
    17c4412a-0acc-4652-92b7-12d68e0d200d
    Distribution End Date
    2022-08-23

    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
    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 10845717009376
    Primary 00845717009379