MasterScope

GUDID 04057155000610

diagnostic spirometer for measurement and data collection of lung function parameters in Clinical Trials

eResearchTechnology GmbH

Diagnostic spirometer

• Primary Device ID: 04057155000610
• NIH Device Record Key: 0d73bd7b-ef3f-4d8c-a5f0-e1dda9b63f31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MasterScope
• Version Model Number: MasterScope CT
• Company DUNS: 341625331
• Company Name: eResearchTechnology 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: true
• 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: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@ert.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com
• Phone: +4993057209891
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082539

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [MasterScope]

• 04057155000061: Spirometer handle to measure inspiratory and expiratory pulmonary function; part of MasterScope
• 04057155000030: diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000023: diagnostic spirometer for measurement and data collection of lung function parameters in Clinica
• 04057155000016: diagnostic Spirometer for measurement and data collection of lung function parameters
• 04057155000627: diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000610: diagnostic spirometer for measurement and data collection of lung function parameters in Clinica
• 04057155000641: diagnostic spirometer for measurement and data collection of lung function parameters with optio
• 04057155000634: diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000566: Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to sof