DEVICE: Electrocardiograph (06944413800342)

Device Identifier (DI) Information

Electrocardiograph
SE-600
In Commercial Distribution

Edan Instruments, Inc.
06944413800342
GS1

1
529173163 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multichannel electrocardiograph, interpretive, professional An instrument designed to be used by a healthcare professional in a clinical setting to measure electrical potentials on the body surface to produce 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 facilitate interpretation of the record by enabling comparison of multiple-lead recordings of the same heartbeat. It performs a computerized analysis of the signals using an internal algorithm and typically provides a print-out ECG with a suggested interpretation and waveform component measurements.
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FDA Product Code

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Product Code Product Code Name
DPS Electrocardiograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e9ad0aab-2a71-4550-a8e5-3f0b222915a0
March 29, 2018
2
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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