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510(k) Data Aggregation
K Number
K122813Device Name
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC.
Date Cleared
2012-12-18
(96 days)
Product Code
DWC
Regulation Number
870.4250Why did this record match?
Applicant Name (Manufacturer) :
CINCINNATI SUB-ZERO PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Device Description
The Hemotherm® Model 400CE Cooler/Heater System is a dual reservoir, water recirculating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. The device uses conductive heat transfer. When ordered by the health care professional, the device can also simultaneously supply temperature controlled water to a blanket to provide additional patient re-warming therapy. If the blanket is used at the same time as the heat exchanger, the blanket is supplied the same water that circulates to the heat exchanger.
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K Number
K121669Device Name
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC.
Date Cleared
2012-07-03
(27 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
CINCINNATI SUB-ZERO PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Device Description
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
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K Number
K120081Device Name
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC.
Date Cleared
2012-02-17
(37 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
CINCINNATI SUB-ZERO PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Device Description
The Cincinnati Sub-Zero Norm-O-Temp (Model 111Z) is a water re-circulating system providing either hyperthermia or normothermia treatment as determined by the health care provider. It is a total body hyperthermia system used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. Water is heated and pumped from the device, through connecting flexible tubing, to disposable or reusable blankets/pads. The blankets/pads rest under, on top of and/or around the patient and are designed so that the water circulates through the blankets/pads and returns back to the device. The device is designed to operate based on the temperature of the circulating water. The system is used in Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms with adult, pediatric and infant (including neonate) patients. The blankets/pads that are used with the Norm-O-Temp system are offered in a variety of sizes from large to small to meet the needs of the patients.
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K Number
K110104Device Name
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC.
Date Cleared
2011-02-04
(22 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
CINCINNATI SUB-ZERO PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blanketrol II Model 222S Hyper-Hypothermia Temperature Management System is used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Device Description
The Blanketrol II Model 222S is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
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K Number
K101589Device Name
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Manufacturer
CINCINNATI SUB-ZERO PRODUCTS, INC.
Date Cleared
2010-09-20
(105 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
CINCINNATI SUB-ZERO PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Device Description
The Blanketrol III/CoolBlue Hyper-Hypothermia System is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
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