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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
TRUDELL MEDICAL INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Thermal Decomposition of Device 1 1
Insufficient Flow or Under Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Computer Software Problem 1 1
Pacing Problem 1 1
Under-Sensing 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Tachycardia 1 1
Skin Burning Sensation 1 1

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