DEVICE: Electrocardiograph (06944413800359)
Device Identifier (DI) Information
Device Characteristics
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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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Electrocardiograph, professional, multichannel | A device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. |
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
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
512df333-d41e-4575-a819-7b3a912d2f27
May 08, 2018
3
September 01, 2016
May 08, 2018
3
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined