Haemodialysis

Main information

  • Trade name:
  • Haemodialysis system dialysate pyrogen filter
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Haemodialysis system dialysate pyrogen filter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218666
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218666

Fresenius Medical Care Australia Pty Ltd - Haemodialysis system dialysate pyrogen filter

ARTG entry for

Medical Device Included Class IIa

Sponsor

Fresenius Medical Care Australia Pty Ltd

Postal Address

Level 17 / 61 Lavender Street,MILSONS POINT, NSW, 2061

Australia

ARTG Start Date

19/12/2013

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

Fresenius Medical Care AG & Co KGaA

Else Kroner Strasse 1

Bad Homburg, Bad Homburg, D-61352

Germany

Products

1. Haemodialysis system dialysate pyrogen filter

Product Type

Single Device Product

Effective date

19/12/2013

GMDN

47739 Haemodialysis system dialysate pyrogen filter

Intended purpose

Dialysis Fluid Filters are designed for the ultrafiltration of dialysis fluid. The fluid filter removes pyrogens

from the dialysate, is located "on-line" in the dialysate fluid path and minimises the risk of pyrogen transfer

into the patient's blood.

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 09:45:47 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