BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    QardioArm

    DI: 00854894005036 · Model: A100 · QARDIO, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    QardioArm
    Primary DI
    00854894005036
    Version / Model
    A100
    Catalog Number
    A100-ILR
    Company Name
    QARDIO, INC.
    Labeler DUNS
    080029958
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2019-11-08
    Public Version Status
    Update
    Public Device Record Key
    d09c0f63-2860-4f86-837f-39b34cd9a4b1

    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
    Yes
    Has Lot/Batch Number
    No
    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
    Primary 00854894005036
    Package 10854894005033

    Premarket Submissions

    Submission Number Supplement Number
    K140067 000