External

Main information

  • Trade name:
  • External defibrillator electrode, adult, single-use
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • External defibrillator electrode, adult, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218497
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218497

Zoll Medical Australia Pty Ltd - External defibrillator electrode, adult, single-use

ARTG entry for

Medical Device Included Class Is

Sponsor

Zoll Medical Australia Pty Ltd

Postal Address

Unit 10/39 Herbert Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

13/12/2013

Product category

Medical Device Class Is

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

Zoll Medical Corporation

269 Mill Road

Chelmsford, MA, 01824-4105

United States Of America

Products

1. External defibrillator electrode, adult, single-use

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

44771 External defibrillator electrode, adult, single-use

Intended purpose

Sterile electrodes intended for use by qualified personnel who are trained in basic life support, or

advanced life support, or other physician-authorized emergency medical response for external

defibrillation, cardioversion, noninvasive pacing, and electrocardiograph monitoring.

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 10.11.2017 at 10:15:24 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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