Device Recall The Sarns Dual CoolerHeater

  • 모델명 / 제조번호(시리얼번호)
    The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160); Dual Cooler Heater 220V/50Hz (P/N 4332); Dual Cooler Heater 1 OOV/60Hz (P/N 14114); Dual Cooler Heater 1 OOV/50Hz (PIN 13460)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic: 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, WA, WI, WV, WY Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Germany Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates , Uruguay , Venezuela, Vietnam
  • 제품 설명
    Preamendments device-Sarns Dual Cooler-Heater. || The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 || pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. || Product Usage: || The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103
  • 제조사 모회사 (2017)
  • Source
    USFDA