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CardioQuip

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30078994243007899424CardioQuip1N2026-01-018422 Calibration Ct College Station TX US 77845

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1578401080901533K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000DWC2010-11-19
1578401039506024
1578401844642314

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWC12010-11-19

PMN#

GUDID#

CardioQuip Thermoelectric Cooling (TEC) Lid Module - 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.

CARDIOQUIP, LLC

2020-12-08

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