Connector

Main information

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

Documents

Localization

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

Other information

Status

  • 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:

220599

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

ARTG entry for

Medical Device Included Class IIa

Sponsor

Flexicare Australia Pty Ltd

Postal Address

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

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

Flexicare Medical Ltd

Cynon Valley Business Park Mountain Ash

, Mid Glamorgan, CF45 4ER

Products

1. Connector, mouthpiece, single-use

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

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