DEVICE: Wireless BT 12 lead resting ECG. (07290110250607)

Device Identifier (DI) Information

Wireless BT 12 lead resting ECG.
Blue ECG
In Commercial Distribution

NORAV MEDICAL LTD.
07290110250607
GS1

1
514773159 *Terms of Use
The Blue-ECG 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 Record Status

074b5ac3-c62a-4c94-bf99-5f42a3e524f8
March 29, 2018
2
October 21, 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
7290110250713 1 07290110250607 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)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+97249893001
info@norav.com
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