Haemodialysis

Main information

  • Trade name:
  • Haemodialysis system operation software
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Haemodialysis system operation software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218990
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218990

Baxter Healthcare Pty Ltd - Haemodialysis system operation software

ARTG entry for

Medical Device Included Class IIb

Sponsor

Baxter Healthcare Pty Ltd

Postal Address

PO Box 88,TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

8/01/2014

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

Gambro Lundia AB Monitor Division

Box 10101

Magistratsvagen 16, 10 Lund, S-220

Sweden

Products

1. Haemodialysis system operation software

Product Type

Single Device Product

Effective date

8/01/2014

GMDN

60638 Haemodialysis system operation software

Intended purpose

Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the

central processing unit (CPU) incorporated into a haemodialysis system or haemodialysis system dialysate

delivery unit. This includes the software or firmware based programs and routines supplied by the

computer manufacturer that drive a specific computer in the performance of its tasks and assists the

operators, applications programmers, and programs with various supporting functions. A proprietary name

and a "version number" are commonly used to identify different operating system versions.

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 08:48:57 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