Pleural Pneumopericardial

Main information

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



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

Other information


  • 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:


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

ARTG entry for

Medical Device Included Class III


William A Cook Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Cook Incorporated

750 Daniels Way

Bloomington, Indiana, 47404

United States Of America


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

Product Type

Medical device system

Effective date



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

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.

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