#Aptalis flutter device code
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = BYI and Original Applicant = BRADSTREET CLINICAL RESEARCH ASSOC., INC. The Flutter valve (Aptalis Pharma US, Inc) consists of a pipe-shaped apparatus with a steel ball in a bowl covered by a. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. INDICATIONS The FLUTTER ® provides positive expiratory pressure (PEP) therapy for patients with mucus-producing respiratory conditions, including: Atelectasis, Bronchitis, Bronchiectasis, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD), Asthma or other conditions producing retained secretions. in the countries of: Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.ġ A record in this database is created when a firm initiates a correction or removal action.
#Aptalis flutter device pdf
Worldwide Distribution - US Nationwide in the states of OH, NM, CO, NC, IL, MD, LA, MN, NJ, SC, AL, VA, MI, MA, and CA. View online (3 pages) or download PDF (59 KB) Aptalis Flutter Mucus Clearance Device Instructions for use Flutter Mucus Clearance Device PDF manual. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 90. The letter identified the affected product, problem and actions to be taken. The affected products has lot numbers S46 and S47.Ĭustomer notification that the device may be difficult to open or close.Īptalis Pharmatech distributed a customer notification letter on November 13, 2014. Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma. Shop Aptalis Us, Inc Ar5891493099 Flutter Mucus Clearance Device,Aptalis Us, Inc - Each 1 online at best prices at desertcart - the best international. Percussor, powered-electric - Product Code BYIįLUTTER Percussor respiratory device, packaged one unit per clear plastic package. flutter device, flutter device price, flutter device for asthma, flutter device for bronchiectasis, flutter device instructions, aptalis flutter device.
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