Tubing

Main information

  • Trade name:
  • Tubing extension set, intravenous administration
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Tubing extension set, intravenous administration
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221942
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221942

Swirl Technologies Pty Ltd T/A Parker Healthcare - Tubing extension set, intravenous administration

ARTG entry for

Medical Device Included Class IIa

Sponsor

Swirl Technologies Pty Ltd T/A Parker Healthcare

Postal Address

16 Redland Drive,MITCHAM, VIC, 3132

Australia

ARTG Start Date

3/04/2014

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

Mediplas Respiratory Products Sdn Bhd

No 7 Jalan KIP 3 Taman Perindustrian KIP

Kuala Lumpur, , 52200

Malaysia

Products

1. Tubing extension set, intravenous administration

Product Type

Single Device Product

Effective date

3/04/2014

GMDN

12170 Tubing extension set, intravenous administration

Intended purpose

Extension Set is a single use flexible hollow tubing of variable size and length, which is used to transfer

fluids or blood to the patient.

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 02.12.2017 at 04:16:58 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