Carbon

Main information

  • Trade name:
  • Carbon dioxide cuvette, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Carbon dioxide cuvette, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221356
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221356

Medtronic Australasia Pty Ltd - Carbon dioxide cuvette, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/03/2014

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

Covidien llc

15 Hampshire Street

Mansfield, MA, 02048

United States Of America

Products

1. Carbon dioxide cuvette, single-use

Product Type

Single Device Product

Effective date

17/03/2014

GMDN

46821 Carbon dioxide cuvette, single-use

Intended purpose

The device is an accessory to the ventilator that allows for a CO2 transducer to read the CO2 in a patient's

breathing circuit.

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 01:22:08 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

31-10-2018

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The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

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Sevelamer carbonate Zentiva (Genzyme Europe B.V.)

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EU/3/18/2014 (IQVIA RDS Ireland Limited)

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EU/3/14/1328 (Roche Registration GmbH)

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