BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rhinomanometer

    DI: 05060485270034 · Model: NR6 · GM INSTRUMENTS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rhinomanometer
    Primary DI
    05060485270034
    Version / Model
    NR6
    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
    2017-11-17
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    cd453142-31d4-4e57-b1b6-d8d99503994a

    Device Description

    An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will be powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.

    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
    17228 Computerized rhinomanometer

    Identifiers

    Type ID
    Primary 05060485270034

    Premarket Submissions

    Submission Number Supplement Number
    K902120 000

    Storage Conditions

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