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510(k) Data Aggregation
K Number
K153162Device Name
Hypocore
Manufacturer
NOVOCOR MEDICAL SYSTEMS, INC
Date Cleared
2016-05-24
(204 days)
Product Code
NCX
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOR MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
Device Description
The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube. During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port. It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off. The entire device is disposable, single use and is provided pre-sterilized.
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