SpiroScout 04421

GUDID 04250972300103

Ganshorn Medizin Electronic GmbH

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 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: 04250972300103
• NIH Device Record Key: e575a874-bd0d-436b-b8f9-e02be037b989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiroScout
• Version Model Number: 04421
• Catalog Number: 04421
• Company DUNS: 318498177
• Company Name: Ganshorn Medizin Electronic GmbH
• 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: true
• 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: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: info@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de
• Phone: +49977162220
• Email: quality@ganshorn.de

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 60 KiloPascal and 105 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250972300103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160116

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-07

On-Brand Devices [SpiroScout]

• 04250972300103: 04421
• 07613365500011: The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings f