Bar-code

Main information

  • Trade name:
  • Bar-code reader
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bar-code reader
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218656
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218656

Tristel Pty Ltd - Bar-code reader

ARTG entry for

Medical Device Included Class 1

Sponsor

Tristel Pty Ltd

Postal Address

144 Church Street,

Brighton, VIC, 3186

Australia

ARTG Start Date

18/12/2013

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

Tristel Solutions Limited

Lynx Business Park Fordham Road

Snailwell, Cambridgeshire, CB8 7NY

Products

1. Bar-code reader

Product Type

Single Device Product

Effective date

18/12/2013

GMDN

37035 Bar-code reader

Intended purpose

A bar-code scanner to assist with recording and traceability of the use of Tristel products.

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 09:47:38 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

10-11-2018

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is...

FDA - U.S. Food and Drug Administration

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

19-10-2018

Reclamecode voor medische cosmetische behandelingen

Reclamecode voor medische cosmetische behandelingen

Vanaf half oktober geldt een reclamecode op reclame voor medische cosmetische behandelingen uitgevoerd door artsen. De code is tot stand gekomen met subsidie van het ministerie van VWS en is opgesteld door de Nederlandse Stichting Esthetische Geneeskunde. De code is onderdeel van de Nederlandse Reclame Code en geldt daarmee voor alle adverteerders in de branche

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

20-9-2018

Cybex International Inc. Recalls Cybex Smith Press

Cybex International Inc. Recalls Cybex Smith Press

A fall hazard has been identified when a user has not fully engaged the weight bar hooks over the pins and has not set the safety stops, permitting the bar to fall near a user. Potential injuries range from minor to significant including paralysis, spinal fracture and injuries to the head and neck.

Health Canada

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

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

6-9-2018

TJX Canada recalls Swivel Barstools

TJX Canada recalls Swivel Barstools

These barstools are being recalled because the wood joints of the barstool can break, posing a fall hazard.

Health Canada

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

2-8-2018

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging

Sweet Earth Foods is initiating a voluntary recall of a limited amount of 8-ounce packages of Sweet Earth Aloha BBQ Quesadilla due to mismatched packaging, resulting in undeclared egg and milk allergens. People who are allergic to eggs or milk could have a serious or life- threatening reaction if they consume this item. A UPC code of 016741000551 appears on the back of the package. The “best by” date of 6/28/19 and lot number of 8149 appears on the side of the package.

FDA - U.S. Food and Drug Administration

3-7-2018

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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

29-6-2018

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® (the Company) is voluntarily recalling specific lot codes of bottles of its Sparkling Ice® Cherry Limeade beverage in response to a small number of customer complaints that reported an off-taste and off-odor of the affected product. The Company made the decision to recall the product out of an abundance of caution.

FDA - U.S. Food and Drug Administration

23-6-2018

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc Dba Honey Mama's Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar

Nectar Foods Inc., DBA Honey Mama's of Portland, Oregon is recalling 79 Sleeves (948 units) of Oregon Peppermint bars, lot code 112918, because it may contain undeclared Almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

15-6-2018

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company Voluntarily Recalls Honey Smacks Cereal Due to Possible Health Risk

Kellogg Company today announced it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s® Honey Smacks® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

FDA - U.S. Food and Drug Administration

26-5-2018

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

GIANT Food Stores, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution following a supplier notification that the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

26-5-2018

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

25-5-2018

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

29-4-2018

UPDATED: Van’s Foods Voluntarily Recalls Gluten Free Waffles Due to Gluten, Undeclared Wheat & Undeclared Milk

UPDATED: Van’s Foods Voluntarily Recalls Gluten Free Waffles Due to Gluten, Undeclared Wheat & Undeclared Milk

Van’s Foods is voluntarily recalling Van’s Gluten Free Waffles with a lot code date of #A640234710–WL2, BEST BY AUG 22, 2018 and UPC 0 89947 30206 4. The products are being recalled because a limited number of the wrong packaging were used during the production of Van’s Belgian Waffles. The product inadvertently packaged in the Van’s Gluten Free Waffle box contains gluten, undeclared wheat and undeclared milk. People who have an allergy or severe sensitivity to milk, wheat or gluten run the risk of serio...

FDA - U.S. Food and Drug Administration

18-1-2018

Updating of summaries of product characteristics due to changed ATC codes for 2018

Updating of summaries of product characteristics due to changed ATC codes for 2018

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2018.

Danish Medicines Agency

16-11-2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Medicines Safety Update, Volume 8, Number 5, October-November 2017

Ibrutinib - ventricular tachyarrhythmia, hepatitis B reactivation and infection; Improving Product Information; Codeine-containing products - use in children and ultra-rapid metabolisers

Therapeutic Goods Administration - Australia

20-1-2017

Updating of summaries of product characteristics due to changed ATC codes for 2017

Updating of summaries of product characteristics due to changed ATC codes for 2017

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2017.

Danish Medicines Agency

7-1-2016

Updating of summaries of product characteristics due to changed ATC codes for 2016

Updating of summaries of product characteristics due to changed ATC codes for 2016

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2016.

Danish Medicines Agency

16-1-2015

Updating of summaries of product characteristics due to changed ATC codes for 2015

Updating of summaries of product characteristics due to changed ATC codes for 2015

Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure, as well as the Mutual Recognition Procedure, should be aware that some ATC codes have been changed in 2015.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

24-9-2018

Diacomit (Biocodex)

Diacomit (Biocodex)

Diacomit (Active substance: Stiripentol) - Centralised - Renewal - Commission Decision (2018)6254 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/664/R/21

Europe -DG Health and Food Safety

27-8-2018

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5703 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3854/T/14

Europe -DG Health and Food Safety

9-8-2018

Consultation: Proposed therapeutic goods advertising code guidance

Consultation: Proposed therapeutic goods advertising code guidance

The TGA is seeking input from interested parties on the revised version of the guidance to support the Code. Closing date: 4 October 2018

Therapeutic Goods Administration - Australia

1-8-2018

Strimvelis (GlaxoSmithKline Trading Services Limited)

Strimvelis (GlaxoSmithKline Trading Services Limited)

Strimvelis (Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - Centralised - Yearly update - Commission Decision (2018)5217 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-7-2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

1-7-2018

Changeover to Therapeutic Goods Advertising Code 2018

Changeover to Therapeutic Goods Advertising Code 2018

The 2018 Code takes effect from 1 January 2019

Therapeutic Goods Administration - Australia

1-6-2018

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages)  https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW pic.twitter.com/bGlnTFOzVE

hydrocodone (Vicodin®), codeine, morphine, and many others. #DYK #FDAInnovationChallenge (2 of 2 messages) https://go.usa.gov/xQwmW  pic.twitter.com/bGlnTFOzVE

FDA - U.S. Food and Drug Administration

25-5-2018

The new Code - where are we at?

The new Code - where are we at?

Webinar and information session on the implementation of the Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia