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510(k) Data Aggregation
K Number
K132202Device Name
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
Manufacturer
ENTHERMICS MEDICAL SYSTEMS, INC.
Date Cleared
2013-12-06
(143 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ENTHERMICS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enthermics Medical Systems DC Series Fluid Warming Cabinets are designed to safely store and warm irrigation fluids and injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
Device Description
The DC Series Fluid Warming Cabinets are single cavity warming cabinets intended to heat either irrigation fluids (set point range of 90°F to 150°F) or injection fluids (set point range of 90°F to 110°F). The cabinets consist of powder coated steel exterior panels, and stainless steel cavity panels. The exterior also consists of ABS plastic panels. The heating system of the device includes three or more independent, fully insulated, electrothermal arrays mounted on the outside of the cavity. The device includes an over temperature alarm which provides an audible and visual indication that the cavity temperature has exceeded the set temperature by 10°F. Additional thermal reset switches are present the shut off power to the heating array or unit in the event of an over temperature array or cavity respectively.
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K Number
K091336Device Name
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
Manufacturer
ENTHERMICS MEDICAL SYSTEMS, INC.
Date Cleared
2010-05-07
(366 days)
Product Code
LGZ, PAN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
ENTHERMICS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ivNow Modular Fluid Warmer is intended to warm injection / IV and irrigation fluid bags to a predetermined temperature, and once warm, to monitor and control the temperature of the fluid in the bags.
Device Description
Enthermics Medical Systems' ivNow Modular Fluid Warmer is designed to rapidly warm and maintain the temperature of injection / IV and irrigation fluid bags. Open on two sides with no cover or door, the device consists of a warming area module (alcove) in a "C" shape with a heating element that warms and maintains the temperature of the fluid. The basic device may be used as a single module or [pre]assembled in multiple configurations comprised of 1-6 modules with a common power switch and cord, fastened together by a unique rear mounting panel. The device is available in either 120v or 230v.
When an injection / IV or irrigation fluid bag is placed in the warming alcove, an optical sensor signals to the control that the alcove is occupied. The control then engages the heating element which warms the fluid in the bag. The temperature of the heating element and fluid is monitored by two sets of sensors contained within the device. When the desired temperature of the fluid is reached and confirmed, the real time temperature of the fluid is displayed on a panel at the front of the device (the control display). Internally, the heating element and fluid temperatures are monitored, and the heating element is regulated to raise the fluid to the desired temperature but never beyond that temperature. When the fluid reaches the desired temperature, the control displays the set temperature and a green indicator light next to the control display turns on. The control will continue to monitor the temperature of the heating element and fluid, and regulate the heating element to maintain the fluid at its set temperature indefinitely. The length of time that a particular bag has been warming in the alcove is also monitored and displayed (total residence time monitor display).
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K Number
K993797Device Name
EC-7701 FLUID WARMING CABINET
Manufacturer
ENTHERMICS MEDICAL SYSTEMS, INC.
Date Cleared
2000-01-20
(72 days)
Product Code
LDQ, LDO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ENTHERMICS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enthermics Medical Systems EC-7701 Fluid Warming Cabinet is designed to safely store and warm irrigation fluids or injection fluids in accordance with the recommended warming temperatures and storage times stated in the fluid manufacturers' labeling.
Device Description
The EC-7701 is a stainless steel fluid warming cabinet that utilizes a fully insulated electrothermal cable array that is wrapped inside the bottom and two sides of the cabinet to provide uniform radiant, conductive and convective heating. The device can be used to heat irrigation fluids to a temperature ranging from 90°F to 150°F, or injection fluids to a range of 90°F to 110°F. The device also contains an over-temperature alarm which provides an audible and visual alarm when the internal temperature reaches 10°F above the selected temperature.
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K Number
K963731Device Name
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
Manufacturer
ENTHERMICS MEDICAL SYSTEMS, INC.
Date Cleared
1997-04-22
(217 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
ENTHERMICS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The function of the ENTHERMICS TRU-5000™ Thermal Recovery Radiant Heating Unit is to provide a safe yet effective means of patient rewarming in the recovery of adult hypothermic human subjects. The use of the TRU-5000 is a physician prescribed therapy for surgically- or trauma-induced hypothermia, with the ultimate responsibility of the patients overall recovery falling on the physician.
Device Description
The TRU-5000 consists of (1) an aesthetically pleasing fiberglass exterior encasing the semicylindrical heating chamber, (2) a modified heat resistant stretcher with a unique lock and key design, (3) a stand-alone, dual-probe, skin temperature audible-alarm system and (4) standard hospital sheets used as insulating drapes. An easy to operate control panel provides quick and easy control of all rewarming operations. The control system includes an LED readout of chamber control temperature, two independent skin temperatures and control setpoint with an audible alarm which sounds whenever the skin temperature setpoint is exceeded. The heating surface temperature controller of the TRU-5000 is factory preset at 70 °C to minimize operator error and provide optimum patient warming. The system requires no additional power demands and includes self diagnostic features to ensure operational accuracy. Quick and easy access to the heating chamber is devised in case of medical intervention.
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