Airway

Main information

  • Trade name:
  • Airway, oropharyngeal, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Airway, oropharyngeal, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216978
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216978

Medical Developments International Limited - Airway, oropharyngeal, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Medical Developments International Limited

Postal Address

PO Box 9004,Scoresby, VIC, 3179

Australia

ARTG Start Date

6/11/2013

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

Foremount Enterprise Co Ltd

17 Alley 15 Lane 5 Shenan Street

Shengang Hsiang Taichung County, Taiwan,

42944

Taiwan (Province of China)

Products

1. Airway, oropharyngeal, single use

Product Type

Single Device Product

Effective date

6/11/2013

GMDN

42424 Airway, oropharyngeal, single use

Intended purpose

A curved plastic tube inserted through the mouth to facilitate airway patency for gas exchange. The device

works by preventing the tongue from obstructing airflow. The device is single use.

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 03:43:23 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