Inflator, tracheal tube cuff

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

Buy It Now

Available from:
Big Green Surgical Company Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
339827

Public Summary

Summary for ARTG Entry:

339827

Big Green Surgical Company Pty Ltd - Inflator, tracheal tube cuff

ARTG entry for

Medical Device Included Class 1

Sponsor

Big Green Surgical Company Pty Ltd

Postal Address

46 Albert Street, PRESTON, VIC, 3072

Australia

ARTG Start Date

20/07/2020

Product Category

Medical Device Class 1

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

Biovo Technologies Ltd

HaArad 5

, Tel Aviv, 69710

Israel

Products

1 . Inflator, tracheal tube cuff

Product Type

Single Device Product

Effective Date

20/07/2020

GMDN

35401 Inflator, tracheal tube cuff

Intended Purpose

Device to measure and regulate, through passive control, intracuff pressures Endotracheal tubes, Tracheotomy tubes and

Laryngeal Masks Airway (supraglottic airways). This device is a single patient use. It is used under medical supervision in hospitals,

pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.

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 22.07.2020 at 08:20:20 AEST

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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