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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
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 3
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4

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