Device Recall Continuous Ventilator

  • 모델명 / 제조번호(시리얼번호)
    Serial No. 1000 thru 2090; P/N 951001
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to IL and TX.
  • 제품 설명
    Intellicuff Standalone (PN 951001) || Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hamilton Medical, Inc., 4990 Energy Way, Reno NV 89502-4123
  • 제조사 모회사 (2017)
  • Source
    USFDA