Sleep

Main information

  • Trade name:
  • Sleep apnoea nasal mask, reusable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sleep apnoea nasal mask, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219618
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219618

BMC CPAP Pty Ltd - Sleep apnoea nasal mask, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

BMC CPAP Pty Ltd

Postal Address

PO Box 3007,ROUSE HILL, NSW, 2155

Australia

ARTG Start Date

25/01/2014

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

BMC Medical Co

Room 110 Tower A Fengyu Building No 115

Fucheng Road Haidian

, Beijing, 100036

China

Products

1. Sleep apnoea nasal mask, reusable

Product Type

Medical device system

Effective date

25/01/2014

GMDN

36033 Sleep apnoea nasal mask, reusable

Intended purpose

A flexible, form-shaped device placed over the nose and designed to direct ambient air, or oxygen (O2)

and air, into the respiratory tract, at a higher pressure than ambient air, to provide positive pressure [e.g.,

continuous positive airway pressure (CPAP), or bi-level positive airway pressure (BiPAP)] to

improve/enhance the sleep of persons experiencing sleep apnoea. It is typically made of plastic, silicone,

or other materials that create an airtight seal around the nasal passages. It typically includes a standard 22

mm connector (adult) or a 15 mm connector (paediatric), and is available in various designs and sizes. It

may be stabilized with a headstrap. This is a reusable device.

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 07:02:27 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

There are no safety alerts related to this product.

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration