Laryngeal Mask

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 28 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model: AMB408-300-000, Affected: 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
  • 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
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