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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, minimal ventilatory support, home use
Regulation Description Continuous ventilator.
Definition This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Product CodeNQY
Regulation Number 868.5895
Device Class 2

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