Airway

Main information

  • Trade name:
  • Airway, laryngeal, single-use
  • Class:
  • Class IIa
  • 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:
  • 220597
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220597

AMBU Australia Pty Ltd - Airway, laryngeal, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

AMBU Australia Pty Ltd

Postal Address

2/1 Prosperity Parade,WARRIEWOOD, NSW, 2102

Australia

ARTG Start Date

28/02/2014

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

Ambu AS

Baltorpbakken 13

Ballerup, , DK-2750

Denmark

Products

1. Airway, laryngeal, single-use

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

45036 Airway, laryngeal, single-use

Intended purpose

Intended to be used in intubation procedures where gastric access is required. The laryngeal mask has a

separate portal to allow access by a gastric lavage tube etc.

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 03:39:29 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