CPAP BiPAP

Main information

  • Trade name:
  • CPAP/BiPAP face mask, reusable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CPAP/BiPAP face mask, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218554
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218554

BMedical Pty Ltd - CPAP/BiPAP face mask, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

BMedical Pty Ltd

Postal Address

PO Box 1388,Fortitude Valley, QLD, 4006

Australia

ARTG Start Date

14/12/2013

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

Circadiance LLC

1060 Corporate Lane

Export, PA, 15632

United States Of America

Products

1. CPAP/BiPAP face mask, reusable

Product Type

Single Device Product

Effective date

14/12/2013

GMDN

57814 CPAP/BiPAP face mask, reusable

Intended purpose

Intended to be used in the treatment of various obstructive respiratory disorders. This is a full face mask

made of light weight material including cloth

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 10.11.2017 at 10:05:48 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