GoSpiro 45-90058
GUDID 00860000692809
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.
MONITORED THERAPEUTICS, INC.
Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional| Primary Device ID | 00860000692809 |
| NIH Device Record Key | 4fa70003-2679-4d3b-9526-b37fb6895237 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GoSpiro |
| Version Model Number | 45-90058 |
| Catalog Number | 45-90058 |
| Company DUNS | 079316129 |
| Company Name | MONITORED THERAPEUTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 17 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 63 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 5 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000692809 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163249
FDA Product Code
| BZG | Spirometer, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-05 |
| Device Publish Date | 2019-02-02 |
Devices Manufactured by MONITORED THERAPEUTICS, INC.
| 00860000692823 - Turbine Assembly, Bagged for GoSpiro Spirometer | 2019-03-25 Turbine Assembly, Bagged for GoSpiro Spirometer |
| 00860000692809 - GoSpiro | 2019-03-05Device 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. |
| 00860000692809 - GoSpiro | 2019-03-05 Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clini |
Trademark Results [GoSpiro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GOSPIRO 86433412 4947132 Live/Registered |
MONITORED THERAPEUTICS, INC. 2014-10-24 |
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