BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    proudP

    DI: 00860006184902 · Model: SU-UFM-001 · Soundable Health, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    proudP
    Primary DI
    00860006184902
    Version / Model
    SU-UFM-001
    Company Name
    Soundable Health, Inc.
    Labeler DUNS
    116957774
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-15
    Public Version
    3
    Public Version Date
    2021-07-13
    Public Version Status
    Update
    Public Device Record Key
    d3373251-3e5b-4310-9637-9b0c3c05913c

    Device Description

    proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at office or at home and required to be used in a quiet environment. This device targets patients over 18 years of age.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    EXY Uroflowmeter

    GMDN Terms

    Code Name
    64362 Home uroflowmetry software

    Identifiers

    Type ID
    Primary 00860006184902