Devices

Device Recall HeaterCooler Device

  • 모델명 / 제조번호(시리얼번호)
    154-10360CE 163-10502CE 163-10512CE  163-10527CE 164-10537CE 163-10491CE  163-10503CE 163-10513CE 163-10528CE  164-10538CE 163-10493CE 163-10504CE  163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE  163-10530CE 164-10540CE 163-10496CE  163-10506CE 163-10521CE 164-10531CE  164-10543CE 163-10497CE 163-10507CE  163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE  164-10533CE 164-10545CE 163-10499CE  163-10509CE 163-10524CE 164-10534CE  164-10547CE 163-10500CE 163-10510CE  163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE  164-10536CE 164-10549CE
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
  • 제품 설명
    The Hemotherm 400CE 115v, containing power board p/n 39945
  • Manufacturer
    Cincinnati Sub-Zero Products Inc
  • 1 Event

제조사

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA