Home

Main information

  • Trade name:
  • Home CPAP unit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Home CPAP unit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218218
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218218

BMC CPAP Pty Ltd - Home CPAP unit

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

6/12/2013

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

BMC Medical Co

Room 110 Tower A Fengyu Building No 115

Fucheng Road Haidian

, Beijing, 100036

China

Products

1. Home CPAP unit

Product Type

Medical device system

Effective date

6/12/2013

GMDN

60711 Home CPAP unit

Intended purpose

Positive airway pressure unit for the management of obstructive sleep apnea and other sleep disordered

breathing conditions capapable of delivering Constant and/or Automatic pressure. Supplied with or without

heated humidifier, with or without nasal or nasal pillow or full face mask and heated or non-heated hose.

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 11:23:06 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

9-11-2018

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Baked Potatoes with Cheddar Cheese and Bacon (2 Count) Mis-Labeled as Herb Roasted Potatoes

Ukrop’s Homestyle Foods is voluntarily recalling Baked Potatoes with Cheddar Cheese and Bacon (2 count), as the product is mislabeled Herb Roasted Potatoes (see photo attached).

FDA - U.S. Food and Drug Administration

5-11-2018

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

The platform on the ladder does not lock securely in place posing a potential fall hazard.

Health Canada

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

6-9-2018

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

FDA - U.S. Food and Drug Administration

6-9-2018

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamina

Beaumont Bio Med, Inc. Issues Voluntary Nationwide Recall of all their Homeopathic Aqueous/Alcohol-Based Medicines due to the Nationwide Recall by the Contract Manufacturer, King Bio, of all their Aqueous-Based Products due to Possible Microbial Contamina

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

28-8-2018

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

FDA - U.S. Food and Drug Administration

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

FDA - U.S. Food and Drug Administration

4-5-2018

 Slime: a very popular toy putty that is not without risk

Slime: a very popular toy putty that is not without risk

ANSES and the DGCCRF are alerting consumers to the risks associated with making and handling "slime". Slime, a sticky and elastic putty for kneading, is currently very popular with children and adolescents. It is commercially available in ready-to-use form or in kits. It can also be made at home, in order to vary its appearance and texture (by adding colour, glitter, etc.). Tutorials on how to make slime have proliferated on the Internet and offer many recipes, based on ingredients such as paper glue and...

France - Agence Nationale du Médicament Vétérinaire

27-10-2017

Keep up with the latest updates on our website

Keep up with the latest updates on our website

Now you can keep up with all updates on the Danish Medicines Agency's website and not only our news items. You can filter the overview by category and month, and the overview is structured in chronological order with the latest update first. You can find a shortcut to the overview on our home page.

Danish Medicines Agency

19-9-2018

If your home was damaged or if you had flood loss due to #Florence, start the recovery process by filing your homeowner’s and flood insurance claims. Insurance is the most effective tool for recovery.

More on filing a flood insurance claim:  http://fema.

If your home was damaged or if you had flood loss due to #Florence, start the recovery process by filing your homeowner’s and flood insurance claims. Insurance is the most effective tool for recovery. More on filing a flood insurance claim: http://fema.

If your home was damaged or if you had flood loss due to #Florence, start the recovery process by filing your homeowner’s and flood insurance claims. Insurance is the most effective tool for recovery. More on filing a flood insurance claim: http://fema.gov/nfip-file-your-claim … pic.twitter.com/lv5Na8Zw8c

FDA - U.S. Food and Drug Administration

19-9-2018

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding:  https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go

As people return home and businesses begin to reopen, #FDA is committed to providing safety tips for the general public and technical assistance for businesses, such as advice on Restaurants and Grocers Reopening After Hurricanes and Flooding: https://go.usa.gov/xP2y6  pic.twitter.com/r3c0i4pose

FDA - U.S. Food and Drug Administration

4-6-2018

EU/3/05/334 (Florence Porte ThomE)

EU/3/05/334 (Florence Porte ThomE)

EU/3/05/334 (Active substance: Human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein) - Transfer of orphan designation - Commission Decision (2018)3629 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/05/T/03

Europe -DG Health and Food Safety

17-5-2018

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration