CARDIOQUIP, LLC

Address:8422 Calibration Ct,College Station,TX,77845,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Controller, Temperature, Cardiopulmonary Bypass (DWC) (4)

Premarket Exempt

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CardioQuip Modular Cooler-Heater (MCH) - 00860000846103 Catalog Number :

Device Description : The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-co The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Device Class : 2

Duns Number: 144183733

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

CardioQuip Modular Cooler-Heater (MCH) - 00860000846110 Catalog Number :

Device Description : The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-co The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Device Class : 2

Duns Number: 144183733

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

CardioQuip Refrigeration Module - 00860000846127 Catalog Number :

Device Description : The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Device Class : 2

Duns Number: 144183733

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

CardioQuip Thermoelectric Cooling (TEC) Lid Module - 00860000846134 Catalog Number :

Device Description : The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the Car The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Device Class : 2

Duns Number: 144183733

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

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