Intravenous

Main information

  • Trade name:
  • Intravenous administration set, heat exchanging
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Intravenous administration set, heat exchanging
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222471
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222471

Getz Healthcare Pty Ltd - Intravenous administration set, heat exchanging

ARTG entry for

Medical Device Included Class IIa

Sponsor

Getz Healthcare Pty Ltd

Postal Address

5 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

14/04/2014

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

Belmont Instrument Corporation

780 Boston Road

Billerica, Massachusetts, 01821

United States Of America

Products

1. Intravenous administration set, heat exchanging

Product Type

Single Device Product

Effective date

14/04/2014

GMDN

41609 Intravenous administration set, heat exchanging

Intended purpose

Administration set to administer blood from pack to 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 09.11.2017 at 09:28:54 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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