Filter, humidifier, heat/moisture exchanger

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

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Available from:
Device Technologies Australia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322674

Public Summary

Summary for ARTG Entry:

322674

Device Technologies Australia Pty Ltd - Filter, humidifier, heat/moisture exchanger

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

4/09/2019

Product category

Medical Device Class IIa

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

Vadi Medical Technology Co Ltd Yangmei

No 198 Lane 298 Huandong Road

ZhongShan Village Yangmei District, Taoyuan

City, 32665

Taiwan

Products

1. Filter, humidifier, heat/moisture exchanger

Product Type

Single Device Product

Effective date

4/09/2019

GMDN

37597 Filter, humidifier, heat/moisture exchanger

Intended purpose

A reusable electrically powered heating unit intended for heating the filter at the expiratory limb of a

breathing circuit to reduce condensation and cross-contamination as the gases pass to the exhalation

system.

Specific Conditions

© 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 02.11.2019 at 05:10:37 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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