Dialysis

Main information

  • Trade name:
  • Dialysis system anticoagulation solution
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Dialysis system anticoagulation solution
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216495
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216495

Fresenius Medical Care Australia Pty Ltd - Dialysis system anticoagulation solution

ARTG entry for

Medical Device Included Class IIb

Sponsor

Fresenius Medical Care Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

23/10/2013

Product category

Medical Device Class IIb

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. Dialysis system anticoagulation solution

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

45815 Dialysis system anticoagulation solution

Intended purpose

Sodium citrate 4% anticoagulant solution is for use only for the anticoagulation of whole blood as part of

automated apheresis procedures and continuous renal replacement therapy. This device cannot be

reused.

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 05:01:40 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

22-6-2018

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA - U.S. Food and Drug Administration

9-11-2011

Danish Pharmacovigilance Update, 20 October 2011

Danish Pharmacovigilance Update, 20 October 2011

In this edition of Danish Pharmacovigilance Update, you can read about: Use of medicines involving a risk of serious and life-threatening skin reactions, the European Medicines Agency to investigate the possible connection between orlistat and rare cases of severe liver toxicity, and the EMA’s review of peritoneal dialysis solutions from Baxter A/S.

Danish Medicines Agency

22-6-2018

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients  https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

FDA - U.S. Food and Drug Administration