Device Recall CDI 500 Blood Parameter Monitoring System

  • 모델명 / 제조번호(시리얼번호)
    1193, 1355, 1356, 1420, 1423, 1464, 1465, 1504, 1521, 1522, 1523, 1524, 1526, 1527, 1529, 1530, 1602, 1603, 1604, 1606, 1662, 2035, 2102, 2103, 2104, 2105, 2106, 2107, 2800, 2901, 2902, 3131, 3132, 3133, 3134, 3135, 3261, 3262 and 4132.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • 제품 설명
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV, Terumo Cardiovascular Systems || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
  • Source
    USFDA