Applied News

Month: November 2014

FDA Registration FAQs

November 24, 2014 by Kristen Cifranic

Below is an FDA requirements cheat sheet with our frequently asked questions. If you are still confused, or looking for more answers, Applied can take the hassle away and register for you!Just give us a call for more information, 1-888-327-7301. How do I know if I have to register with the FDA? Anyone who fills, or private labels the gas MUST register. (21 CFR 207.20) How often is it required to register? Registration must be done annually, and it must be submitted between October 1 and December 31 of the year. (21 CFR 207.21(a), 21 USC 360(b)) Should I register before I begin transfilling, or should I wait until my system is operating? Registration must be done within 5 days of starting filling. (21 CFR 207.21 (a)) Can I register without filling out the drug listing? Everyone who registers must do a drug listing. (21 CFR 207.21 (a)) You only submit a drug listing, after the initial reporting, if there are updates. (21 CFR 207.30(b)) Why didnt the FDA assign me an FEI number? The

Posted in FDA Registration, Transfilling Oxygen, Drug Listing

An Overview of Applied Training Workbooks

November 12, 2014 by Kristen Cifranic

When you receive your Applied Training Workbook, review the text and watch the DVD (if applicable), then make a copy of the master exam, complete it and send it to us for grading! If you pass with 70% or more (and we know you will!) we will send you a frameable certificate to prove training. (Each certificate is a nominal fee, but you can take the exam as many times as you like during the year.) Each workbook is updated yearly. OF-1290 DOT in Plain English: A Guide to Federal Law. This course explains and cites all US DOT law as it relates to home oxygen providers. A great resource to answer the question: Who said so? when discussing delivery requirements. This training aid focuses on the rules and regulations promulgated by the United States Department of Transportation (US DOT). Essentially, the DOT requires you to outfit your vehicle in a certain way, train employees on certain topics and to carry certain papers in your vehicle. This book will cover the law and guidance relevant

Posted in Trainingworkbooks, Trainingaids, DOTinPlainEnglish, FederalLawoncGMP, OxyFillGastoGasRefillingSystem, OxyFillLiquidtoGasOxygenRefillingSystem

Medical Oxygen Regulators FAQ

November 05, 2014 by Kristen Cifranic

Applied is one of the leading medical oxygen regulator suppliers in the home healthcare industry and here are some of our most frequently asked questions (FAQ): 1. Are all regulators made in China the same from a quality perspective? No, some medical regulator suppliers, like Applied, engineer and do final testing of regulators in the U.S. This insures that providers and ultimately patients receive a quality regulator that will deliver the proper prescription of oxygen specified by the healthcare professional. 2. How can I determine the quality of a medical oxygen regulator? First, purchase medical devices such as medical oxygen regulators only from a quality, established, and qualified supplier. This ensures if you have a question or a problem you can get answers and solutions. Next, given the number of Chinese regulators in the market, it helps to have individual regulator testing data with the regulator(s) to ensure quality and performance. 3. Do medical regulators require periodic

Posted in Regulators, Medicaloxygen, CGA

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