Tubing

Main information

  • Trade name:
  • Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung bypass
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung bypass
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221857
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221857

Getinge Australia Pty Ltd - Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung

bypass

ARTG entry for

Medical Device Included Class III

Sponsor

Getinge Australia Pty Ltd

Postal Address

PO Box 50,BULIMBA, QLD, 4171

Australia

ARTG Start Date

1/04/2014

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

Maquet Cardiopulmonary AG

38 Hechinger Strasse

Hirrlingen, Hirrlingen, D72145

Germany

Products

1. Tubing Set with Bioline Coating without oxygenator - Tubing set, heart-lung bypass

Product Type

Single Device Product

Effective date

1/04/2014

GMDN

35441 Cardiopulmonary bypass system tubing set

Functional description

The Bioline coated tubing sets are designed to be used for transportation of blood and other liquids

between the patient and the extracorporeal system.

Intended purpose

Maquet's Bioline coated tubing sets consisting of tubing, connectors, filters and various other items are

designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures.

Variant information

Model number (see guidance docs) BE-H 46343

Diameter (mm) 1.6 -16

Model number (see guidance docs) BE-H 89500

Model number (see guidance docs) BE-H 46338

Model number (see guidance docs) BE-H 46334

Model number (see guidance docs) BE-H 46305

Model number (see guidance docs) BE-H 46302

Model number (see guidance docs) BE-H 100200

Model number (see guidance docs) BE-H 87420

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 09.11.2017 at 11:34:18 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