Filter

Main information

  • Trade name:
  • Filter, bacteria, breathing circuit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Filter, bacteria, breathing circuit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220575
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220575

Bosco Medical Australia - Filter, bacteria, breathing circuit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Bosco Medical Australia

Postal Address

2/49 Borthwick Avenue,MURARRIE, QLD, 4172

Australia

ARTG Start Date

27/02/2014

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

Inmed Manufacturing Sdn Bhd

Lot PT 2577 Jalan Perusahaan 4

, Kamunting Perak, 34600

Malaysia

Products

1. Filter, bacteria, breathing circuit

Product Type

Single Device Product

Effective date

27/02/2014

GMDN

35070 Filter, bacteria, breathing circuit

Intended purpose

A filter device installed in breathing systems and gas sampling lines to protect the patient circuit and/or

repirator or ventilator or anaesthesia machine from contamination

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 03:44:26 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

22-8-2018

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The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

27-10-2017

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