Analgesia

Main information

  • Trade name:
  • Analgesia unit, inhalation
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Analgesia unit, inhalation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222055
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222055

Gascon Systems Ltd - Analgesia unit, inhalation

ARTG entry for

Medical Device Included Class IIa

Sponsor

Gascon Systems Ltd

Postal Address

PO Box 284,BALWYN NORTH, VIC, 3104

Australia

ARTG Start Date

7/04/2014

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

O-Two Medical Technologies Inc

7575 Kimbel Street

Mississauga, Ontario, L5S 1C8

Canada

Products

1. Analgesia unit, inhalation

Product Type

Single Device Product

Effective date

7/04/2014

GMDN

16953 Analgesia unit, inhalation

Intended purpose

Delivery of an analgesic gas mixture of Nitrous Oxide and Oxygen for the demand inhalation of

patients, to relieve pain in situations such as obstetrics, minor surgery, burn dressing, and transport of

accident victims.

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

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Public Summary

Page 1 of

Produced at 09.11.2017 at 10:56:10 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