BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Amazon Basic Care

    DI: 00195515047951 · Model: B09S3VLQLL · AMAZON.COM SERVICES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Amazon Basic Care
    Primary DI
    00195515047951
    Version / Model
    B09S3VLQLL
    Company Name
    AMAZON.COM SERVICES LLC
    Labeler DUNS
    128990418
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-21
    Public Version
    1
    Public Version Date
    2023-12-29
    Public Version Status
    New
    Public Device Record Key
    8a8fc3cc-d580-4cab-b208-9580e0920f31

    Device Description

    Amazon Basic Care Blood Pressure Monitor Adult Wrist Cuff

    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 10195515047958
    Primary 00195515047951