PocketECG IV – Unified Arrhythmia Diagnostic System

GUDID 05903021560087

The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AB-ADS is inteded for use in LTE cellular networks.

MEDICALGORITHMICS S A

Electrocardiography telemetric monitoring system

• Primary Device ID: 05903021560087
• NIH Device Record Key: 07ad370a-e4c5-4782-9934-070b8542e1a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PocketECG IV – Unified Arrhythmia Diagnostic System
• Version Model Number: P4TR-AB-ADS
• Company DUNS: 522657576
• Company Name: MEDICALGORITHMICS S A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05903021560087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193104

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-14

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

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