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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device n95 respirator with antimicrobial/antiviral agent
Definition A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Product CodeONT
Regulation Number 878.4040
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sore Throat 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1