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510(k) Data Aggregation
K Number
K031544Device Name
HEATER COOLER UNIT, MODEL HCU 30
Manufacturer
JOSTRA AB
Date Cleared
2003-08-07
(83 days)
Product Code
DWC
Regulation Number
870.4250Why did this record match?
Applicant Name (Manufacturer) :
JOSTRA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Device Description
The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchangers, for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The water temperature is adjustable from 1°C to 41°C. A 26 litre tank with ice and approx. 1ºC cold water assures quick cooling of the patient. Two independent circuits with separate temperature controls can be attached (the main side has two connections). A safety system monitors the regulation in order to prevent the temperature from rising above 42°C.
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