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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device external airway
Definition This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Product CodePMB
Regulation Number 868.5105
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
Blister 1 1

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