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Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG

Primary DI
05903021560001
Brand
Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG
Company
MEDICALGORITHMICS S A
Model
Type: PC Client
Device description
The PC Client software is an accessory to the Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III and Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV. The PC Client application allows managing the recording sessions and reviewing the ECG data that was recorded by the patient monitors.
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124060000MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEMMedicalgorithmics S.A.2013-02-21DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903021560001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903021560001059030215600015903021560001

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
522657576
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903021560834DeepRhythmAIType: DRAI2026-03-25
05903021560742DeepRhythmAIType: DRAI2025-06-06
05903021560223PocketECG IV - Unified Arrhythmia Diagnostic SystemP3HL-AB-UNI2025-12-04
05903021560131DeepRhythmAIType: DRAI2022-08-05
05903021560018PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-III2018-01-09
05903021560025PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-IIIV2018-01-09
05903021560032PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGB-III2018-01-09
05903021560049PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGC-III2018-01-09
05903021560056PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation SystemType: PECGT-IIIR2018-08-21
05903021560698DeepRhythm PlatformDeepRhythm Platform2024-12-20
05903021560124Q PatchP5HP-AA-ADS2022-06-23
05903021560155Q Patch Mobile Application1.02022-06-23
05903021560162Q Patch Downloader9.482022-06-23
05903021560070PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AA-ADS2020-08-14
05903021560087PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AB-ADS2020-08-14
05903021560094PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AA-UNI2020-08-14
05903021560100PocketECG IV – Unified Arrhythmia Diagnostic SystemP3CH-AB-UNI2020-08-14
05903021560117PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AB-UNI2020-08-14
05903021560063PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGH-III2018-08-21

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