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.
07290110252519
GS1

1
514773159 *Terms of Use
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.
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Device Characteristics

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

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.
Active false
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FDA Product Code

[?]
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 [?]
K000404 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

66f264ad-a1e5-492f-80d9-e6537c67e951
March 10, 2021
7
January 03, 2017
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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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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+97249893001
support@norav.com
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