DEVICE: 12 lead ECG for rest. (07290110252854)

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Device Identifier (DI) Information

12 lead ECG for rest.
PCECG 1200M

NORAV MEDICAL LTD.
07290110252854
GS1
1
The 1200M sub-model is an ECG acquisition boxe for use in the PCECG 1200 system. The 1200M is used for Stress test in clinics and hospitals. The sub-model collects data in 12 channels and transfer to the PCECG 1200 software on the PC. The 1200M acquisition box receives its power from the PC via USB connection. On the other end it is connected to standard ECG electrodes which are applied on the patient body via ECG patient cables.
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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
Electrocardiographic signal amplifier An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.
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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
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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 26, 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
7290110250782 1 07290110252854 In Commercial Distribution
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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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