Basic

Main information

  • Trade name:
  • Basic endotracheal tube, single-use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Basic endotracheal tube, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216700
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216700

Carlin Medical Supply Pty Ltd - Basic endotracheal tube, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Carlin Medical Supply Pty Ltd

Postal Address

PO Box 700,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

30/10/2013

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

Welford UK Ltd

145-157 St John Street

, London, EC1V 4PW

Products

1. Basic endotracheal tube, single-use

Product Type

Single Device Product

Effective date

30/10/2013

GMDN

46967 Basic endotracheal tube, single-use

Intended purpose

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey

gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the

patient is not properly ventilated. The device is typically made of plastic or rubber and is available in

various diameters and lengths for adult and paediatric patients. This is a single-use device.

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 04:31:14 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

10-11-2018

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Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

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Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

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Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

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31-7-2018

Heat wave: Retailers may refrain from selling non-prescription drugs

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Due to the summer heat, the Danish Medicines Agency has given Danish retailers dispensation from the requirement to stock a basic selection of medicines if they are having trouble keeping the temperature in their store cool enough for proper storage of the drugs. This dispensation applies until 1 September.

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The Facts on Tampons—and How to Use Them Safely

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Tampons are medical devices regulated by the U.S. Food and Drug Administration. And if you or a loved one uses them, it's important to use them safely. Learn the basics and consider this advice.

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