BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GoSpiro

    DI: 00860000692809 · Model: 45-90058 · MONITORED THERAPEUTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GoSpiro
    Primary DI
    00860000692809
    Version / Model
    45-90058
    Catalog Number
    45-90058
    Company Name
    MONITORED THERAPEUTICS, INC.
    Labeler DUNS
    079316129
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-02-02
    Public Version
    3
    Public Version Date
    2022-03-08
    Public Version Status
    Update
    Public Device Record Key
    4fa70003-2679-4d3b-9526-b37fb6895237

    Device Description

    Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device. The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection. It is used with the GoSpiro App display and communications software on a smartphone or tablet. The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test. Indications for Use: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZG Spirometer, Diagnostic

    GMDN Terms

    Code Name
    13680 Diagnostic spirometer, professional

    Identifiers

    Type ID
    Primary 00860000692809

    Customer Contacts

    Phone
    614-761-3555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K163249 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    17 – 35 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    63 – 95 Degrees Fahrenheit
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    0 – 5 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 70 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    4 – 158 Degrees Fahrenheit