BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Microlife

    DI: 04719003315047 · Model: BP3SZ1-1CEN · MICROLIFE USA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Microlife
    Primary DI
    04719003315047
    Version / Model
    BP3SZ1-1CEN
    Catalog Number
    WatchBP O3 2G
    Company Name
    MICROLIFE USA, INC.
    Labeler DUNS
    176387785
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-27
    Public Version
    1
    Public Version Date
    2024-12-05
    Public Version Status
    New
    Public Device Record Key
    945668fa-84ce-49ba-ac0b-971483df7665

    Device Description

    WatchBP O3 2G(BP3SZ1-1) CBP type

    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
    Yes
    Has Manufacturing Date
    Yes
    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
    64510 Arrythmia-detection blood pressure ambulatory recorder

    Identifiers

    Type ID
    Package 14719003315044
    Primary 04719003315047
    Package 24719003315041