PocketECG IV – Unified Arrhythmia Diagnostic System

GUDID 05903021560117

The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.

MEDICALGORITHMICS S A

Electrocardiography telemetric monitoring system
Primary Device ID05903021560117
NIH Device Record Key7f85172e-0be2-4653-ae52-0d86bd6f443c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePocketECG IV – Unified Arrhythmia Diagnostic System
Version Model NumberP4BA-AB-UNI
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
GS105903021560117 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14

On-Brand Devices [PocketECG IV – Unified Arrhythmia Diagnostic System]

05903021560117The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic
05903021560100The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Di
05903021560094The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic
05903021560087The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic Sys
05903021560070The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic Sys

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