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510(k) Data Aggregation
K Number
K102900Device Name
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
Manufacturer
Date Cleared
2012-03-21
(538 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HEI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HEITER 3000 Hyperthermic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as sterile saline or Lactated Ringers.
Device Description
The HEITER 3000 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics. The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The HEITER 3000 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
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