Turbine Assembly, Bagged for GoSpiro Spirometer 45-90133

GUDID 00860000692823

Turbine Assembly, Bagged for GoSpiro Spirometer

MONITORED THERAPEUTICS, INC.

Diagnostic spirometer

• Primary Device ID: 00860000692823
• NIH Device Record Key: c6660362-94c9-4a2d-a9cb-4e99bdbfb234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Turbine Assembly, Bagged for GoSpiro Spirometer
• Version Model Number: 45-90133
• Catalog Number: 45-90133
• 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

• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com
• Phone: 614-761-3555
• Email: jim.kamnikar@monitoredrx.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling Environment Temperature: Between 4 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000692823 [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: 2019-03-25
• Device Publish Date: 2019-03-17

Devices Manufactured by MONITORED THERAPEUTICS, INC.

• 00860000692823 - Turbine Assembly, Bagged for GoSpiro Spirometer: 2019-03-25Turbine Assembly, Bagged for GoSpiro Spirometer
• 00860000692823 - Turbine Assembly, Bagged for GoSpiro Spirometer: 2019-03-25 Turbine Assembly, Bagged for GoSpiro Spirometer
• 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