Ambix

Main information

  • Trade name:
  • Ambix Intraport CP Powerflow - Port, infusion, implantable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ambix Intraport CP Powerflow - Port, infusion, implantable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222676
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222676

Fresenius Kabi Australia Pty Limited - Ambix Intraport CP Powerflow - Port, infusion, implantable

ARTG entry for

Medical Device Included Class III

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

22/04/2014

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

Fresenius Kabi AG

Else-Kroner-strasse 1

Bad Homburg, , D-61346

Germany

Products

1. Ambix Intraport CP Powerflow - Port, infusion, implantable

Product Type

Procedure Pack

Effective date

22/04/2014

GMDN

35911 Port, infusion, implantable

Functional description

Completely implantable catheter system consisting of a PEEK casing, an aluminium oxide ceramic

medicine compartment with a silicone membrane and a polyurethane catheter which can be connected to

the port casing.

Intended purpose

Indicated when treatments require long-term, repeated access to the venous vascular system. Medicines,

intravenous infusions, parenteral nutrition or blood products, for example, can be applied via the venous

port systems. Also suitable for blood sampling purposes and high-pressure injection/infusion.

Variant information

Nil variant (as 1 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 09.11.2017 at 08:36:06 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