Pleural Pneumopericardial

Main information

  • Trade name:
  • Pleural/Pneumopericardial Drainage Set - Drainage system, pleural
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pleural/Pneumopericardial Drainage Set - Drainage system, pleural
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220713
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220713

William A Cook Australia Pty Ltd - Pleural/Pneumopericardial Drainage Set - Drainage system, pleural

ARTG entry for

Medical Device Included Class III

Sponsor

William A Cook Australia Pty Ltd

Postal Address

95 Brandl St Brisbane Technology Park,EIGHT MILE PLAINS, QLD, 4113

Australia

ARTG Start Date

5/03/2014

Product category

Medical Device Class III

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

Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America

Products

1. Pleural/Pneumopericardial Drainage Set - Drainage system, pleural

Product Type

Medical device system

Effective date

5/03/2014

GMDN

10817 Drainage system, pleural

Functional description

The Pleural/Pneumopericardial Drainage Set may consist of a pigtail catheter, introducer needle, pigtail

straightener and multipurpose tubing adaptor, 6cc monoject syringe, mini scalpel, disposable mosquito

haemostat, clear three-way stopcock and drape.

Intended purpose

The Pleural/Pneumopericardial Drainage Set is used for evacuation of air from the peicardial sac or

drainage of air or fluid from the pleural space.

Variant information

Guage (French) Size 5 or 6

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 03:22:12 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