BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Acoustic Rhinometer

    DI: 05060485270027 · Model: A1 · GM INSTRUMENTS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Acoustic Rhinometer
    Primary DI
    05060485270027
    Version / Model
    A1
    Catalog Number
    N/A
    Company Name
    GM INSTRUMENTS LIMITED
    Labeler DUNS
    771009610
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b90e4cc6-fa08-4abb-a66d-bf0d17170885

    Device Description

    A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery. A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient's nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the output and return signals to produce plots of cross-sectional areas as a function of distance in the nose.

    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
    BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)

    GMDN Terms

    Code Name
    57974 Acoustic rhinometer

    Identifiers

    Type ID
    Primary 05060485270027

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    20 – 80 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    -40 – 60 Degrees Celsius