DEVICE: 12 lead ECG for rest and stress. (07290110250812)
Device Identifier (DI) Information
12 lead ECG for rest and stress.
PCECG 1200S
In Commercial Distribution
1200S-D-00U-01
NORAV MEDICAL LTD.
PCECG 1200S
In Commercial Distribution
1200S-D-00U-01
NORAV MEDICAL LTD.
PC-ECG Acquisition Device for Stress-Test ECG recordings with AHA type labelling.
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? |
---|---|---|---|---|
36719 | Electrocardiographic signal amplifier |
An electrical device that amplifies the signal level and provides impedance matching between two or more medical devices when bioelectrical signals from the heart are transmitted between them.
|
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 [?] |
---|---|
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
7bc4ffed-42de-4e7c-9491-6f49f86adb86
September 30, 2019
4
October 26, 2016
September 30, 2019
4
October 26, 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 |
---|---|---|---|---|---|
7290110250843 | 1 | 07290110250812 | In Commercial Distribution | Carton box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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