Main information

  • Trade name:
  • Connector, mouthpiece, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Connector, mouthpiece, single-use
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220599
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Flexicare Australia Pty Ltd - Connector, mouthpiece, single-use

ARTG entry for

Medical Device Included Class IIa


Flexicare Australia Pty Ltd

Postal Address

C/o 16 Elmstead Drive,WHEELERS HILL, VIC, 3150


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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.




Flexicare Medical Ltd

Cynon Valley Business Park Mountain Ash

, Mid Glamorgan, CF45 4ER


1. Connector, mouthpiece, single-use

Product Type

Single Device Product

Effective date



44545 Connector, mouthpiece, single-use

Intended purpose

To be inserted into the patient's mouth and connect, via tubing, with a therapeutic or diagnostic respiratory

device. The mouthpiece will provide a gas-tight fitting to the patient's respiratory system through the simple

insertion into the mouth and the patient closing his/her lips around it.

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

Public Summary

Page 1 of

Produced at 10.11.2017 at 03:38:58 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.

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