DEVICE: MasterScope ECG (04057155000054)
Device Identifier (DI) Information
MasterScope ECG
MasterScope ECG
In Commercial Distribution
eResearchTechnology GmbH
MasterScope ECG
In Commercial Distribution
eResearchTechnology GmbH
diagnostic device for ECG measurement and data collection
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Multichannel electrocardiograph, signal-averaging | An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously to simplify and facilitate interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It is noninterpretive and reduces signal noise level by performing an average of multiple cycles of the signal; it may be used to detect late potentials for the identification of patients prone to ventricular tachycardia. |
FDA Product Code
[?]Product Code | Product Code Name |
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DPS | Electrocardiograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9b74f7ba-d9da-4f95-880e-2c18df36a37d
March 29, 2018
2
July 29, 2016
March 29, 2018
2
July 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1800 7049698
CustomerCare@ert.com +4993057209891
CustomerCare@ert.com
CustomerCare@ert.com +4993057209891
CustomerCare@ert.com