MasterScope ECG

GUDID 04057155000054

diagnostic device for ECG measurement and data collection

eResearchTechnology GmbH

Multichannel electrocardiograph, signal-averaging

• 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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• 04057155000672 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000689 - SpiroSphere: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
• 04057155000696 - SpiroSphere: 2024-07-30 Diagnostic device for ECG measurement and data collection
• 04057155000795 - iSpiro Ultrasonic Sensor: 2024-07-30 Diagnostic spirometer for measurement and data collection of lung function parameters.
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