Laryngoscope

Main information

  • Trade name:
  • Laryngoscope Blade, Rigid, Single Use
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Laryngoscope Blade, Rigid, Single Use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216376
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216376

C R Kennedy & Co Pty Ltd - Laryngoscope Blade, Rigid, Single Use

ARTG entry for

Medical Device Included Class IIa

Sponsor

C R Kennedy & Co Pty Ltd

Postal Address

PO Box 82,PORT MELBOURNE, VIC, 3207

Australia

ARTG Start Date

23/10/2013

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

Galemed Corporation

10F No 109 Sec 6 Min-chiuan E Road

Taipei, , 114

Taiwan (Province of China)

Products

1. Laryngoscope Blade, Rigid, Single Use

Product Type

Single Device Product

Effective date

23/10/2013

GMDN

46828 Laryngoscope Blade, Rigid, Single Use

Intended purpose

The section of a rigid laryngoscope that is inserted into the oral cavity to control tongue, to prevent it from

impeding the throat, and capable for a clear view of the trachea for an endotracheal tube to insert before

the inhalation anesthesia delivery or ventilation. Sterile blade is to assist in the entry and positioning of an

endotracheal tube into the trachea (a persons airway). It is connected to a video Laryngoscopic handpiece

to enable direct visualisation of the larynx and correct positioning of an endotracheal tube.

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 23.11.2017 at 04:07:04 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