BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hermano

    DI: B791U80EHBT0 · Model: U80EH-BT · HARMONIZE INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hermano
    Primary DI
    B791U80EHBT0
    Version / Model
    U80EH-BT
    Company Name
    HARMONIZE INC.
    Labeler DUNS
    117022733
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-14
    Public Version
    1
    Public Version Date
    2019-10-22
    Public Version Status
    New
    Public Device Record Key
    4f16ea1b-1994-44b3-9e09-44e1a5566538

    Device Description

    System, measurement, blood-pressure, non-invasive

    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
    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
    36551 Patient monitoring system module, blood pressure, noninvasive

    Identifiers

    Type ID
    Primary B791U80EHBT0

    Premarket Submissions

    Submission Number Supplement Number
    K160019 000