FDA-Device2021-10-13Class II
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
CardioQuip, LLC
Hazard
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
Affected count
369 uniyd
Manufactured in
8422 Calibration Ct, College Station, TX, United States
Products
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2022Don't want to check this manually?
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