DEVICE: ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin (07290110252519)
Device Identifier (DI) Information
ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin
ECG-LAN (Green)
In Commercial Distribution
ECG-LAN-GREEN-K-00-01
NORAV MEDICAL LTD.
ECG-LAN (Green)
In Commercial Distribution
ECG-LAN-GREEN-K-00-01
NORAV MEDICAL LTD.
Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16231 | Electrocardiograph, professional, multichannel |
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MWI | Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K000404 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
66f264ad-a1e5-492f-80d9-e6537c67e951
March 10, 2021
7
January 03, 2017
March 10, 2021
7
January 03, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97249893001
support@norav.com
support@norav.com