Zensoronline software

GUDID 05060484630044

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The

INTELESENS LIMITED

Electrocardiography telemetric monitoring system
Primary Device ID05060484630044
NIH Device Record Key216d01a3-ac86-43c5-a77b-bd4f5c58bf8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameZensoronline software
Version Model NumberPN0810
Company DUNS231959888
Company NameINTELESENS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060484630044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-15

Devices Manufactured by INTELESENS LIMITED

15060484630089 - ZENSOR2019-02-07 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con
05060484630099 - Zensor electrode2019-01-21 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three
15060484630003 - ZENSOR2018-07-06 The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system con
05060484630044 - Zensoronline software2018-07-06The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The
05060484630044 - Zensoronline software2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens'
05060484630051 - Zensor+ software2018-07-06 The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens'
15060484630010 - Zensor electrode2018-06-14 The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three
05060484630020 - Aingeal2018-03-29 The Intelesens Aingeal is used to monitor and transmit physiological data to a remote application for display or analysis by a c
25060484630031 - Aingeal 3-patch electrode2018-03-29 The Aingeal 3-Patch Electrode Array is an electrocardiograph (ECG), respiration and temperature electrode. It is a disposable, p

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