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510(k) Data Aggregation
K Number
K070112Device Name
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
Manufacturer
MEDCOOL INC
Date Cleared
2007-07-13
(183 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
MEDCOOL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RapidCool™ Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.
Device Description
The RapidCool™ Patient Temperature Management System reduces, and/or maintains patient body temperature at a desired level by removing heat from a patient's body. The major components of the RapidCool system consist of a Control Console, body surface cooling appliances, tubing sets, and an esophageal temperature sensor. The body surface cooling appliances consist of a back cooling pad, a right axilla-cooling pad, a neck cooling pad, and a head-cooling cap. The control console supplies cold water to the surface cooling appliances, and controls the operation of the system. Tubing sets connect the control console to the surface cooling appliances. The esophageal temperature sensor is connected to the control console and is used to display and patient body temperature.
Body temperature can be reduced and/or maintained in a temperature range between 32 to 37 degrees centigrade by a thermostatic control feature of the control console. The operator can select the desired body temperature within this range.
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