CardioQuip LLC

Entity profile compiled from public source records

Public Record Profile Registrations: 1 510(k) filings: 0 Recalls: 4

Known Identifiers & Locations

FEI Numbers 3007899424
Owner Operator Numbers 10044068
Locations Covered College Station, TX, US

Registered Establishments (1)

Registration # Establishment Name Location Establishment Type(s) Action
3007899424 CardioQuip College Station, TX, US Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (4)

Recall # Product Description Initiation Date Status Action
Z-0035-2022 CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. 2021-05-12 Open, Classified View Details
Z-0036-2022 CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127 Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. 2021-05-12 Open, Classified View Details
Z-0037-2022 CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110 Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. 2021-05-12 Open, Classified View Details
Z-0038-2022 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134 Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. 2021-05-12 Open, Classified View Details

Profile Disclaimer

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