DEVICE: Ambulatory ECG Analysis Software (07290110252748)
Device Identifier (DI) Information
Ambulatory ECG Analysis Software
NH301
In Commercial Distribution
NORAV MEDICAL LTD.
NH301
In Commercial Distribution
NORAV MEDICAL LTD.
ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41651 | Electrocardiographic long-term ambulatory recording analyser application software |
A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
86af519d-2672-431e-9d07-1cf7faaaaff2
September 30, 2019
3
October 13, 2016
September 30, 2019
3
October 13, 2016
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
info@norav.com
info@norav.com