Laryngoscope, intubation

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

Buy It Now

Available from:
Airway Medical Innovations Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321548

Public Summary

Summary for ARTG Entry:

321548

Airway Medical Innovations Pty Ltd - Laryngoscope, intubation

ARTG entry for

Medical Device Included Class 1

Sponsor

Airway Medical Innovations Pty Ltd

Postal Address

Level 3 The Precinct TCB Building 315 Brunswick Street,Fortitude Valley, QLD, 4006

Australia

ARTG Start Date

9/08/2019

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

Airway Medical Innovations Pty Ltd

Level 3 The Precinct TCB Building 315

Brunswick Street

Fortitude Valley, QLD, 4006

Australia

Products

1. Laryngoscope, intubation

Product Type

Single Device Product

Effective date

9/08/2019

GMDN

15076 Laryngoscope, intubation

Intended purpose

15076 - Rigid Intubation Laryngoscope, single-use:

A hand-held device (i.e., non-endoscopic rigid type) intended to be inserted into the oral cavity to

manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the

trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or

ventilation. The device incorporates a light source (LED, conducted by fiber optic tube to keep light out of

the tube) to illuminate the larynx during the procedure of laryngoscopy. A fully sealed coin battery mounted

with the top cap powers the LED. Once the endotracheal tube is loaded into the laryngoscope the user

then can use just one hand to manually, mechanically feed the tube using their thumb on the carrier

mechanism. This is a single-use device.

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 07:25:24 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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