Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100

  • 모델명 / 제조번호(시리얼번호)
    2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A.  2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
  • 제품 설명
    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 || The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    LMA North America Inc, 4660 La Jolla Village Dr Ste 900, San Diego CA 92122-4608
  • 제조사 모회사 (2017)
  • Source
    USFDA