Pleural

Main information

  • Trade name:
  • Pleural catheter
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pleural catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219961
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219961

Tacmed Australia Pty Ltd - Pleural catheter

ARTG entry for

Medical Device Included Class IIa

Sponsor

Tacmed Australia Pty Ltd

Postal Address

PO Box 334,COFFS HARBOUR, NSW, 2450

Australia

ARTG Start Date

7/02/2014

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

North American Rescue LLC

35 Tedwall Court

Greer, SC, 29650-4791

United States Of America

Products

1. Pleural catheter

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

37482 Pleural catheter

Intended purpose

A sterile needle designed to be inserted through an intercostal space and into the pleural cavity (potential

space between the serous membranes covering the lungs) to establish a channel for the removal of air

causing a pneumothorax to permit full expansion of the lungs. 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 05:52:53 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