Cool-Cap

Device typeExternal circulating-fluid core temperature regulation system control unit, cooling-only: An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to lower a patient’s core body temperature. The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery).

FDA categoryCap,Cooling (Infants)

Device ID00382830009577

Catalog number60026

Single useYes

LatexNot made with natural rubber latex

MRI safetyLabeling does not contain MRI Safety Information