MasterScope ECG

GUDID 04057155000054

diagnostic device for ECG measurement and data collection

eResearchTechnology GmbH

Multichannel electrocardiograph, signal-averaging Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

• Primary Device ID: 04057155000054
• NIH Device Record Key: 9b74f7ba-d9da-4f95-880e-2c18df36a37d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MasterScope ECG
• Version Model Number: MasterScope ECG
• 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: 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: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: 1800 7049698
• Email: CustomerCare@ert.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com
• Phone: +1 908 5952020
• Email: CustomerCare@clario.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057155000054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082539

FDA Product Code

• DPS: Electrocardiograph

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: 2016-07-29

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• 04057155000337 - Rotationsflowgeber: 2021-03-19 Rotary flow sensor for single-patient use, accessory to Asthma Monitor
• 04057155000719 - SpiroSphere: 2021-02-26 Main Unit of diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000726 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000757 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000764 - SpiroSphere: 2021-02-26 Diagnostic spirometer for measurement and data collection of lung function parameters
• 04057155000566 - MasterScope: 2021-02-22 Spirometer sensor to measure inspiratory and expiratory pulmonary function for connection to software