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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device burn resuscitation decision support software
Regulation Description Predictive pulmonary-function value calculator.
Definition The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Product CodePDT
Regulation Number 868.1890
Device Class 2

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