Tracheoesophageal speech valve occluder, non-valved

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

Buy It Now

Available from:
Main Medical Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
323181

Public Summary

Summary for ARTG Entry:

323181

Main Medical Pty Ltd - Tracheoesophageal speech valve occluder, non-valved

ARTG entry for

Medical Device Included Class IIa

Sponsor

Main Medical Pty Ltd

Postal Address

PO Box 34,CHURCH POINT, NSW, 2105

Australia

ARTG Start Date

13/09/2019

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

Freudenberg Medical LLC

1110 Mark Ave

Carpinteria, CA, 93013-2918

United States Of America

Products

1. Tracheoesophageal speech valve occluder, non-valved

Product Type

Single Device Product

Effective date

13/09/2019

GMDN

62119 Tracheoesophageal speech valve occluder, non-valved

Intended purpose

Blom Singer TEP Plugs are intended to seal the inner lumen of the voice valve and therefore stop leakage

of both air and fluids through the voice valve.

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 08.11.2019 at 10:43:07 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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