Alkaline Wash

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
    SMPA

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model: List Number: 9D31-20, Affected: Lot Number: 49059UN14
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot number 49059UN14, Expiration data 04-MAR-2016.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia, Austria, Croatia, Denmark, France, India, Isreal, Bermuda, Curacao, Cayman Islands, Jamaica, Canada, Bangladesh, Cyprus, Estonia, Greece, Indonesia, Italy, Kazakhstan, Latvia, Macedonia, Norway, Portugal, Russia, Slovakia, Spain, Taiwan, UAE, Kenya, Lithuania, Malaysia, Philippines, Qatar, Saudi Arabia, Slovenia, Sweden, Tunisia, United Kingdom, Kuwait, Luxembourg, Netherlands, Poland, Romania, Singapore, South Africa, Switzerland, Turkey, and Vietnam.
  • 제품 설명
    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
  • Manufacturer
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