DEVICE: ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin (07290110252519)

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Device Identifier (DI) Information

ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin
ECG-LAN (Green)
ECG Module
NORAV MEDICAL LTD.
07290110252519
GS1
1
The ECGLAN (GREEN) model, which is part of the PCECG1200 system With Modular ECG Analysis System (MEANS), is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The system acquires ECG data and displays it on the color monitor, calculates and controls some parameters of ECG display such as sweep speed, filters line interference and muscle noises introduced during monitoring, makes necessary outputs, handles the user interface, and controls the flow of operations. Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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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
MWI Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
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Sterilization

No
No
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 Status

In Commercial Distribution
January 03, 2017

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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
No Package DIs found
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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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+97249893001
support@norav.com
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