Basic intravenous administration set

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Fresenius Kabi Australia Pty Ltd
Class:
Class Is
Authorization status:
Included
Authorization number:
322584

Public Summary

Summary for ARTG Entry:

322584

Fresenius Kabi Australia Pty Ltd - Basic intravenous administration set

ARTG entry for

Medical Device Included Class Is

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

2/09/2019

Product category

Medical Device Class Is

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

61346

, Bad Homburg,

Germany

Products

1. Basic intravenous administration set

Product Type

Single Device Product

Effective date

2/09/2019

GMDN

58977 Basic intravenous administration set

Intended purpose

A sterile device designed for gravitational fluid administration from an intravenous IV fluid container into

patients.

Specific Conditions

© 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 02.11.2019 at 05:25:32 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

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