Multifunction cardiac electrode, adult

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Vyaire Medical Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
290840

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Public Summary

Summary for ARTG Entry:

290840

CareFusion Australia 316 Pty Ltd - Multifunction cardiac electrode, adult

ARTG entry for

Medical Device Included Class IIb

Sponsor

CareFusion Australia 316 Pty Ltd

Postal Address

PO Box 355,SEVEN HILLS, NSW, 2147

Australia

ARTG Start Date

30/06/2017

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Leonhard Lang Gmbh

Archenweg 56

, Innsbruck, 6020

Austria

Products

1. Multifunction cardiac electrode, adult

Product Type

Single Device Product

Effective date

30/06/2017

GMDN

45806 Multifunction cardiac electrode, adult

Intended purpose

A non-sterile electrical conductor designed to be applied to an adult patient for automatic or manual

defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of

cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals

and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s),

defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive

gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead

wires. This is a single-use device.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 03.11.2017 at 02:41:21 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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