Bed

Main information

  • Trade name:
  • Bed, infant, general-purpose
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bed, infant, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217487
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217487

Care Quip - Bed, infant, general-purpose

ARTG entry for

Medical Device Included Class 1

Sponsor

Care Quip

Postal Address

PO Box 6308,SILVERWATER, NSW, 2128

Australia

ARTG Start Date

19/11/2013

Product category

Medical Device Class 1

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

Care Quip

5 Millennium Court

SILVERWATER, NSW, 2128

Australia

Products

1. Bed, infant, general-purpose

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

38140 Bed, infant, general-purpose

Intended purpose

A general purpose bed or crib designed for newborn babies.

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 02:12:10 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

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

Natural Life Pet Products of Saint Louis, Missouri is voluntarily recalling our Chicken & Potato dry dog food (described below) due to it containing elevated levels of Vitamin D.

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruno Bruins voor Medische Zorg en Sport heeft vandaag de Green Deal ‘Duurzame zorg voor een gezonde toekomst’ getekend. Hiermee maken 132 partijen uit de zorg, overheid en bedrijfsleven afspraken om de zorg in Nederland duurzamer te maken. Inzet is het terugdringen van CO2-uitstoot, zuiniger gebruik van grondstoffen, minder medicijnresten in het water en een gezonde leefomgeving voor patiënt, cliënt en zorgmedewerkers.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-10-2018

Prijsonderhandelingen dure medicijnen leiden tot forse kostenverlaging

Prijsonderhandelingen dure medicijnen leiden tot forse kostenverlaging

Sinds enkele jaren onderhandelt de minister voor Medische Zorg met fabrikanten van nieuwe en zeer dure geneesmiddelen. Doel is om deze waardevolle innovatieve geneesmiddelen tegen aanvaardbare kosten toegankelijk te maken en te houden voor de patiënt. Dit heeft in 2017 geleid tot een kostenverlaging van in totaal 132 miljoen euro. Dat heeft minister Bruno Bruins aan de Tweede Kamer laten weten. Op basis van de prijs die fabrikanten eerst vroegen zou er sprake zijn van 457 miljoen aan uitgaven aan de betr...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-9-2018

Blokhuis: Samen aan de slag met nieuwe aanpak onbedoelde zwangerschappen

Blokhuis: Samen aan de slag met nieuwe aanpak onbedoelde zwangerschappen

In de komende jaren investeert staatssecretaris Paul Blokhuis (VWS) 53 miljoen euro in een nieuwe aanpak voor het voorkomen van en begeleiden bij onbedoelde (tiener)zwangerschappen. Op scholen wordt de komende jaren meer aandacht besteed aan gezond seksueel gedrag en anticonceptie. Er komt een landelijke campagne over bewust anticonceptiegebruik en de consequenties van onbedoelde zwangerschap. Kennisinstellingen gaan extra onderzoek doen naar wat in de praktijk het beste werkt om onbedoelde zwangerschapp...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

29-6-2018

Nationaal Sportakkoord ondertekend

Nationaal Sportakkoord ondertekend

Ruim 700 extra buurtsportcoaches, verhoging van de onbelaste vrijwilligersvergoeding van €1500 naar €1700 euro per jaar, €87 miljoen aan subsidie voor sportverenigingen die investeren in accommodaties, een nieuwe code goed sportbestuur en beweegprogramma’s voor kinderen onder de 6 jaar. Dit is slechts een greep uit het sportakkoord dat minister Bruno Bruins (Sport)heeft gesloten met de sport, gemeenten en maatschappelijke organisaties en bedrijven. Het is de eerste keer dat zoveel partijen zijn samengebr...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

Ministers: voedselveiligheid verder versterken urgent

Ministers: voedselveiligheid verder versterken urgent

De Commissie Sorgdrager heeft een grondige analyse gemaakt van de wijze waarop de fipronilcrisis is afgehandeld en spreekt alle relevante actoren –het bedrijfsleven, de toezichthouders en departementen– aan op hun functioneren. Het beeld dat het rapport schetst is niet fraai. De pluimveehouders die nog steeds met de gevolgen van de crisis kampen, voelen het als geen ander.  De aanbevelingen om de voedselveiligheid verder te versterken worden opgevolgd. Dat schrijven de ministers Bruno Bruins en Carola Sc...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

25-6-2018

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Commissie onderzoek fipronil in eieren: geef voedselveiligheid topprioriteit

Bedrijven in de eierketen, de NVWA en de ministeries van VWS en LNV hebben onvoldoende voorrang gegeven aan voedselveiligheid. Bedrijven in de eierketen maken hun wettelijke verantwoordelijkheid niet waar. Bij de NVWA krijgt voedselveiligheid te weinig aandacht. Politiek en bestuur hebben een te beperkte opvatting over hun eigen rol ten aanzien van voedselveiligheid en komen pas in actie als zich een incident of crisis voordoet. Dat zijn de belangrijkste conclusies uit het rapport van de Commissie onderz...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

10-4-2017

Hospital Beds - Risk of Patient Entrapment

Hospital Beds - Risk of Patient Entrapment

MedEffect Canada

3-3-2011

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of glucosamine (M01AX05)

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of glucosamine (M01AX05)

Clinical studies have called into question the efficacy of glucosamine for the alleviation of painful osteoarthritis. This has contributed to the Danish Medicines Agency’s decision to initiate ad hoc reassessment of glucosamine-containing medicines, which today have general conditional reimbursement when prescribed for the alleviation of symptoms of mild to moderate osteoarthritis and when prescribed to old-age pensioners.

Danish Medicines Agency

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

11-6-2018

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (Active substance: Meningococcal group B Vaccine (rDNA, component, adsorbed)) - Centralised - 2-Monthly update - Commission Decision (2018)3769 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2333/II/59

Europe -DG Health and Food Safety

5-6-2018

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovation

#DYK The misuse of prescription drugs means taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria. #FDAInnovationChallenge pic.twitter.com/QI0mrJactV

FDA - U.S. Food and Drug Administration