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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device respirator, n95, for use by the general public in public health medical emergencies
Regulation Description Filtering facepiece respirator for use by the general public in public health medical emergencies.
Definition It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.
Product CodeNZJ
Regulation Number 880.6260
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 5
2021 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Confusion/ Disorientation 1 1
Dyspnea 1 1
Headache 1 1
Viral Infection 1 2
Insufficient Information 1 2
Low Oxygen Saturation 1 1
Dizziness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Office Depot Inc II Sep-28-2020
2 Whirlpool Corporation II Aug-14-2020
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