Humidifier

Main information

  • Trade name:
  • Humidifier, heated
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Humidifier, heated
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221516
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221516

Resmed Limited - Humidifier, heated

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Resmed Limited

Postal Address

Regulatory Affairs / 1 Elizabeth Macarthur Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

20/03/2014

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

Resmed Limited

1 Elizabeth Macarthur Drive

BELLA VISTA, NSW, 2153

Australia

Products

1. Humidifier, heated

Product Type

Single Device Product

Effective date

20/03/2014

GMDN

12050 Humidifier, heated

Intended purpose

ResMed humidifiers are indicated for the humidification of air delivered to the airway during continuous,

automatic and bilevel

therapy. ResMed humidifiers are used in conjunction with ResMed Flow Generators.

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 12:47:56 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.