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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device infant positioner, rx, use in highly monitored setting
Regulation Description Pediatric position holder.
Definition Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.
Product CodeOUW
Regulation Number 880.5680
Device Class 1