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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Andnesfit Health

    DI: 04897100310056 · Model: ADF-B19 · ANDESFIT LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Andnesfit Health
    Primary DI
    04897100310056
    Version / Model
    ADF-B19
    Company Name
    ANDESFIT LIMITED
    Labeler DUNS
    664101036
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-08
    Public Version
    1
    Public Version Date
    2022-02-16
    Public Version Status
    New
    Public Device Record Key
    60483fa1-851f-4550-9307-21165f307732

    Device Description

    Wireless Arm Type Blood Pressure Monitor

    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
    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
    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
    16173 Automatic-inflation electronic sphygmomanometer, non-portable

    Identifiers

    Type ID
    Primary 04897100310056