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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, respiratory, mask (direct patient interface)
Definition Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
Product CodeOBN
Regulation Number 868.5450
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1