PocketECG III – Medicalgorithmics Unified Arrhythm

GUDID 05903021560018

The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System and is intended to: acquire, an

MEDICALGORITHMICS S A

Electrocardiography telemetric monitoring system
Primary Device ID05903021560018
NIH Device Record Key4dc97c00-2246-4bd2-9710-1303de24d6fb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePocketECG III – Medicalgorithmics Unified Arrhythm
Version Model NumberType: PECGT-III
Company DUNS522657576
Company NameMEDICALGORITHMICS S A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105903021560018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDetector And Alarm, Arrhythmia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-23
Device Publish Date2018-01-09

On-Brand Devices [PocketECG III – Medicalgorithmics Unified Arrhythm]

05903021560063The holster type PECGH-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrh
05903021560049The battery charger type PECGC-III is an accessory to the PocketECG III - Medicalgorithmics Unif
05903021560032The battery type PECGB-III is an accessory to the PocketECG III - Medicalgorithmics Unified Arrh
05903021560025The PocketECG transmitter is a key component of the PocketECG III - Medicalgorithmics Unified Ar
05903021560018The PocketECG transmitter is a key component of PocketECG III - Medicalgorithmics Unified Arrhyt
05903021560001The PC Client software is an accessory to the PocketECG III - Medicalgorithmics Unified Arrhythm

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