SpiroScout 04421

GUDID 04250972300103

Ganshorn Medizin Electronic GmbH

Diagnostic spirometer

• 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