Tubing

Main information

  • Trade name:
  • Tubing, oxygen delivery
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tubing, oxygen delivery
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221406
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221406

Medical Developments International Limited - Tubing, oxygen delivery

ARTG entry for

Medical Device Included Class IIa

Sponsor

Medical Developments International Limited

Postal Address

PO Box 9004,Scoresby, VIC, 3179

Australia

ARTG Start Date

18/03/2014

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

Enter Medical Co

66-5 Yao Tzu Chu Tsai Kung Village

Hsin Kang Township, Chia Yi County, 616

Taiwan (Province of China)

Products

1. Tubing, oxygen delivery

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

12875 Tubing, oxygen delivery

Intended purpose

A transparent, flexible hollow tubing, used in conjunction with the delivery of dry oxygen to a mask or nasal

cannula. This tubing will be dedicated for the delivery of oxygen gas. The tubing is supplied in lengths

and/or may be cut by clinical staff to appropriate lengths to create an extension or connecting piece. This

device is single-use.

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 01:10:25 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