Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only,

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
  • 제품 설명
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, || Product Usage: || A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA