Q Patch Mobile Application

GUDID 05903021560155

Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients

MEDICALGORITHMICS S A

Electrocardiography telemetric monitoring system
Primary Device ID05903021560155
NIH Device Record Key08317455-ab56-4082-b1c9-37dd29998b28
Commercial Distribution StatusIn Commercial Distribution
Brand NameQ Patch Mobile Application
Version Model Number1.0
Company DUNS522657576
Company NameMEDICALGORITHMICS S A
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
GS105903021560155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-01
Device Publish Date2022-06-23

Devices Manufactured by MEDICALGORITHMICS S A

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05903021560124 - Q Patch2022-07-01 The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). T
05903021560155 - Q Patch Mobile Application2022-07-01Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients
05903021560155 - Q Patch Mobile Application2022-07-01 Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with t
05903021560162 - Q Patch Downloader2022-07-01 Q Patch Downloader (PC application) – The intended use of the Q Patch Downloader application is to download the data from comp
05903021560070 - PocketECG IV – Unified Arrhythmia Diagnostic System2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire,
05903021560087 - PocketECG IV – Unified Arrhythmia Diagnostic System2020-08-24 The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire,
05903021560094 - PocketECG IV – Unified Arrhythmia Diagnostic System2020-08-24 The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended
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