TAGECG WEARABLE SENSOR


Product Overview

TAGECG WEARABLE SENSOR
Welch Allyn, Inc. - 901098


Device Description

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: DSH

Device Name: Recorder, Magnetic Tape, Medical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2800

Third Party Flag: Y

Medical Specialty: CV


Device Identifiers

Device Id: 00732094212471

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00732094246896

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A


Device Id: 00732094246896

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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