DEVICE: CloudEKG (04650075330081)

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Device Identifier (DI) Information

CloudEKG
CloudEKG

NEUROSOFT, OOO
04650075330081
GS1
1
The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals. Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology. The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals. CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings. All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.
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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 An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).
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FDA Product Code

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Product Code Product Code Name
DXH Transmitters And Receivers, Electrocardiograph, Telephone
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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
September 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
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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617 8403253
Jjabre@teleemg.com
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