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:
  • 222745
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222745

Rapp Australia Pty Ltd - Airway, oropharyngeal, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Rapp Australia Pty Ltd

Postal Address

PO Box 120,LARA, VIC, 3212

Australia

ARTG Start Date

24/04/2014

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

Mercury Medical

11300 49th Street

CLEARWATER, FLORIDA, 34622-4800

United States Of America

Products

1. Airway, oropharyngeal, single use

Product Type

Single Device Product

Effective date

24/04/2014

GMDN

42424 Airway, oropharyngeal, single use

Intended purpose

A curved plastic tube inserted through the mouth to facilitate airway patency for gas exchange or

suctioning. The device works by preventing the tongue from obstructing airflow it resides in the

oropharynx. This device is single use. It is for short term 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 09.11.2017 at 07:56:41 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