Device Recall AV Loop Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 102810, 010311 and 111810.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
  • 제품 설명
    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. || Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Transonic Systems Inc, 34 Dutch Mill Rd, Warren Road Business Park, Ithaca NY 14850-9785
  • 제조사 모회사 (2017)
  • Source
    USFDA