Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number:408300000  Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914   Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075.   Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Please see attached consignee list
  • 제품 설명
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile || for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ambu Inc., 6230 Old Dobbin Ln Ste 250, Columbia MD 21045-5955
  • 제조사 모회사 (2017)
  • Source
    USFDA