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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device holding chambers, direct patient interface
Regulation Description Nebulizer.
Definition Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles
Product CodeNVP
Regulation Number 868.5630
Device Class 2


Premarket Reviews
ManufacturerDecision
THAYER MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 3 3
Inadequacy of Device Shape and/or Size 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Foreign Body In Patient 2 2
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 FSC Laboratories, Inc II Jun-15-2016
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