Airway

Main information

  • Trade name:
  • Airway, laryngeal, single-use
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Airway, laryngeal, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218044
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218044

Gnana Medical Australia Pty Ltd - Airway, laryngeal, single-use

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Gnana Medical Australia Pty Ltd

Postal Address

7B Athol Avenue,TRANMERE, SA, 5073

Australia

ARTG Start Date

4/12/2013

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

Zhejiang Sungood Technology Co Ltd

1F B zone of 2F 3F Bldg 1 No550 Yinhai Street

Economic Development Zone

Hangzhou, Zhejiang, 310018

China

Products

1. Airway, laryngeal, single-use

Product Type

Single Device Product

Effective date

4/12/2013

GMDN

45036 Airway, laryngeal, single-use

Intended purpose

Used for cardiopulmonary resuscitation and during surgery used to allow anesthetic gases and oxygen to

enter into patient's lungs. Contains a small inbuilt suction for collecting saliva.

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 12:09:10 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