Chest-oscillation airway secretion-clearing system

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

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Available from:
Ascencia Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322140

Public Summary

Summary for ARTG Entry:

322140

Ascencia Pty Ltd - Chest-oscillation airway secretion-clearing system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Ascencia Pty Ltd

Postal Address

28 Waverley Park Drive,MULGRAVE, VIC, 3170

Australia

ARTG Start Date

22/08/2019

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

Respinnovation SAS

611 Chemin de l'Ardrech

, Seillans, 83440

France

Products

1. Chest-oscillation airway secretion-clearing system

Product Type

Medical device system

Effective date

22/08/2019

GMDN

38124 Chest-oscillation airway secretion-clearing system

Intended purpose

The RespIn 11 is intended to provide bronchial clearance therapy when external manipulation of the

thorax is the physician's choice of treatment. Indications for this form of therapy are described by the

American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural

Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of

the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having

difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the

RespIn 11 is also indicated for external manipulation of the thorax to promote bronchial clearance or

improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation

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 06:20:43 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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