Puritan

Main information

  • Trade name:
  • Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221416
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221416

Medtronic Australasia Pty Ltd - Puritan Bennett™ 980 Series Ventilators - Ventilator, adult

ARTG entry for

Medical Device Included Class IIb

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

18/03/2014

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

Covidien llc

15 Hampshire Street

Mansfield, MA, 02048

United States Of America

Products

1. Puritan Bennett™ 980 Series Ventilators - Ventilator, adult

Product Type

Medical device system

Effective date

18/05/2017 9:54:53 AM

GMDN

42411 Ventilator, adult

Intended purpose

The ventilator system is intended to deliver selectable modes of respiratory support or mechanical

ventilation to neo natal, pediatric and adult patients, invasively or non-invasively. The device is indicated

for use in hospitals or during intra hospital transport.

The system comprises a breath delivery unit, a graphical user interface and optionally a compressor.

The device is contraindicated for use in a magnetic resonance imaging (MRI) environment.

Specific Conditions

Within 5 business days from the date of receipt of this notice, the sponsor of the Device must provide to all hospitals and other facilities to which the

Device has been supplied in Australia a notice that complies with the requirements set out in Attachment A.

The requirements are specified in the letter dated 9 May 2017 from Adriana Platona MDPQD - NOTICE OF IMPOSITION OF CONDITION ON THE

PURITAN BENNETT 980 SERIES VENTILATOR INCLUDED IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS ENTRY 221416, File

Reference: D17-349237.

© 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 01:09:05 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

8-3-2018

Puritan Bennett 980 Series Ventilator

Puritan Bennett 980 Series Ventilator

New suspension - Medtronic Puritan Bennett 980 Series Ventilator

Therapeutic Goods Administration - Australia

There are no news related to this product.