Condensate

Main information

  • Trade name:
  • Condensate trap, general-purpose, reusable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Condensate trap, general-purpose, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219963
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219963

Masimo Australia Pty Ltd - Condensate trap, general-purpose, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

Masimo Australia Pty Ltd

Postal Address

Suite 3 Building 7 / 49 Frenchs Forest Road,FRENCHS FOREST DC, NSW, 2086

Australia

ARTG Start Date

7/02/2014

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

Masimo Sweden AB

Svardvagen 15 Danderyd

, , SE-182 33

Sweden

Products

1. Condensate trap, general-purpose, reusable

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

31286 Condensate trap, general-purpose, reusable

Intended purpose

This device is designed for use in a breathing circuit or together with a device where water condensate

accumulates quite rapidly due to high degree of humidity in the gases/air that pass through. It will facilitate

the periodical removal of the accumulated liquid which can be discarded without interruption of the ongoing

treatment or process. This is a reusable device.

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 05:52:23 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