BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pylo Health

    DI: 00860004709527 · Model: 1775-N · Prevounce Health, Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pylo Health
    Primary DI
    00860004709527
    Version / Model
    1775-N
    Company Name
    Prevounce Health, Inc
    Labeler DUNS
    116961530
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-24
    Public Version
    2
    Public Version Date
    2023-09-20
    Public Version Status
    Update
    Public Device Record Key
    6bd88dc0-ce01-41d1-a842-0eee1d9836cb

    Device Description

    Non-invasive digital 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
    Yes
    Has Lot/Batch Number
    No
    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
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Package 10860004709524
    Primary 00860004709527