DEVICE: WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set (07290110250485)

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Device Identifier (DI) Information

WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set
PCECG 1200W

NORAV MEDICAL LTD.
07290110250485
GS1
1
The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value
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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
Electrocardiography telemetric monitoring system transmitter A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device.
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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

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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 Status

In Commercial Distribution
October 13, 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
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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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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+97249893001
info@norav.com
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