Humidifier

Main information

  • Trade name:
  • Humidifier, heat/moisture exchange, single use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Humidifier, heat/moisture exchange, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218103
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218103

Teleflex Medical Australia Pty Ltd - Humidifier, heat/moisture exchange, single use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Teleflex Medical Australia Pty Ltd

Postal Address

PO Box 1114,MASCOT, NSW, 1460

Australia

ARTG Start Date

5/12/2013

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

Teleflex Medical Sdn Bhd

Lot PT 2577 Jalan Perusahaan 4 Kamunting

Perak

, , 34600

Malaysia

Products

1. Humidifier, heat/moisture exchange, single use

Product Type

Single Device Product

Effective date

5/12/2013

GMDN

35530 Humidifier, heat/moisture exchange, single use

Intended purpose

The Trach-Vent Holder placed on a tracheostomy tube eases the change of the Trach-Vent Heat and

Moisture Exchanger. Especially important for newly operated patients when tracheostoma is sensitive.

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 11:50:15 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

5-9-2018

Hawthorne Hydroponics LLC recalls Ideal-Air 175 pint Industrial Grade Humidifiers

Hawthorne Hydroponics LLC recalls Ideal-Air 175 pint Industrial Grade Humidifiers

The humidifiers can overheat while in use, posing a risk of fire and electrical shock.

Health Canada

There are no news related to this product.