Electrode, electrocardiograph, single use

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

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Available from:
Cardinal Health Australia 503 Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339472

Public Summary

Summary for ARTG Entry:

339472

Cardinal Health Australia 503 Pty Ltd - Electrode, electrocardiograph, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Cardinal Health Australia 503 Pty Ltd

Postal Address

Level 2 / 5 Eden Park Drive, North Ryde, NSW, 2113

Australia

ARTG Start Date

14/07/2020

Product Category

Medical Device Class 1

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

Cardinal Health 200 LLC also T/a Cardinal

Health

3651 Birchwood Drive

Waukegan, Illinois, 60085

United States Of America

Products

1 . Electrode, electrocardiograph, single use

Product Type

Single Device Product

Effective Date

14/07/2020

GMDN

35035 Electrode, electrocardiograph, single use

Intended Purpose

Intended to be applied to the surface of the body to enable transmission of electrical signals (to a processor) from the intact skin.

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 22.07.2020 at 09:27:07 AEST

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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