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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
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
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 3 3
Gradient Increase 1 1
Use of Device Problem 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
Foreign Body In Patient 2 2
Skin Burning Sensation 1 1
No Known Impact Or Consequence To Patient 1 1
Dyspnea 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
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