ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin ECG-LAN-GREEN-K-00-01

GUDID 07290110252519

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.

NORAV MEDICAL LTD.

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel
Primary Device ID07290110252519
NIH Device Record Key66f264ad-a1e5-492f-80d9-e6537c67e951
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin
Version Model NumberECG-LAN (Green)
Catalog NumberECG-LAN-GREEN-K-00-01
Company DUNS514773159
Company NameNORAV MEDICAL LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com
Phone+97249893001
Emailsupport@norav.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110252519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-09-30
Device Publish Date2017-01-03

Devices Manufactured by NORAV MEDICAL LTD.

07290110255480 - Norav 1200 Series PC-ECG2020-06-11 Kit includes: PC-ECG 1200HR (UDI: 07290110255497) for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG-Trigge
07290110255497 - Norav 1200 Series PC-ECG2020-06-11 PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG-Trigger Output and AHA type la
07290110253080 - Norav NR Series2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR1 (UDI: 7290110253073) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
07290110253103 - Norav NR Series2019-11-08 Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling.
07290110253141 - Norav NR Series2019-11-08 Kit includes: Norav Wireless 3In1 Acquisition Device NR1 (UDI: 7290110253134) for Resting-ECG combined with Respiration and Body
07290110254728 - Norav NR Series2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254698) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
07290110254742 - Norav NR Series2019-11-08 Kit includes: Norav Ambulatory ECG Recording Unit NR2 (UDI: 7290110254711) for Ambulatory ECG Monitoring (Holter-ECG), 12ch., ma
07290110254780 - Norav NR Series2019-11-08 Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling.
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