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  1. www.fda.gov › medical-devices › medical-device-recallsIPV Device Recall: Percussionaire Removes Phasitron Breathing...

    6 dni temu · Affected Product. Product Names: Phasitron 5 breathing circuits ; Part Numbers/Lot Numbers: P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625

  2. www.accessdata.fda.gov › cdrh_docs › pdf22Michael Judge 2412 Pari Way Trade/Device Name: eRapid Nebulizer...

    The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can...

  3. www.fda.gov › medical-devices › medical-device-recallsPhasitron Breathing Circuit Kits Recalled for Over-Pressurization

    2 cze 2024 · Percussionaire is recalling their High Frequency Transport Phasitron Breathing Circuit Kits due to a product defect that causes over-pressurization. There are two parts of the Phasitron kit that...

  4. www.accessdata.fda.gov › scripts › cdrh510(k) Premarket Notification - Food and Drug Administration

    3 dni temu · Nebulizer (Direct Patient Interface) 510(k) Number: K060399: Device Name: LC SPRINT NEBULIZER: Applicant: PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAKLAKE BLVD. MIDLOTHIAN, VA 23112 Applicant Contact: ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination Products; Advisory Committees;

  5. www.accessdata.fda.gov › cdrh_docs › pdf19January 23, 2020 PARI Respiratory Equipment, Inc.

    The PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication...

  6. www.ondrugdelivery.com › eflow-technology-nebulisers-with-digital-therapy-parieFLOW TECHNOLOGY NEBULISERS WITH DIGITAL THERAPY MANAGEMENT: THE...

    10 gru 2021 · Carola Fuchs and Simon Buchner describe PARI’s new nebuliser and digital Connect eco-system and how it supports patients, directly and indirectly, through carefully considered device usability in combination with digital therapy management solutions.

  7. www.atsjournals.org › doi › fullPhilips Respironics Recall of Positive Airway Pressure and...

    The U.S. Food and Drug Administration (FDA) advised on July 22, 2021, that more than 1,200 complaints and 100 injuries were reported on this issue . The duration of exposure necessary to produce symptoms has not been reported or is unknown.

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