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Infant Positioner, Rx, Use In Highly Monitored Setting

FDA product code OUW · 1 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.5680
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2018-01-18 – 2018-01-18

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.

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