Ventilator

Manufacturer

  • Manufacturer Address
    Seoul, Korea 16
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    KFDA

745 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog numbers 4116640 and 8412980
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada.
  • Product Description
    Evita 4 Continuous Ventilator
  • Manufacturer
  • Model / Serial
    All Codes.
  • Distribution
    Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina.
  • Product Description
    ESPRIT VENTILATOR, Model V1000
  • Manufacturer
  • Model / Serial
    Serial numbers: VS300430, VS3004361, VS3004335, VS3004301, VS3004327, VS3004353, VS3004377, VS3004366, VS3004328, VS3004337, VS3004357, VS3004385, VS3004369, VS3004295, VS3004310, VS3004292, VS3004305, VS3004381, VS3004296, VS3004299.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
  • Product Description
    Esprit Ventilator.
  • Manufacturer
  • Model / Serial
    All Codes.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.
  • Product Description
    Espirit Ventilator, Model V1000 || Continuous Ventilator with Respiratory Mechanics
  • Manufacturer
  • Model / Serial
    Restricted to those ventilators with production serial numbers beginning with a ''00'' prefix.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuela.
  • Product Description
    Infant Ventilators with Electronic Manometer. || Models IV-100B; IV-200 and IV-200 SAVI.
  • Manufacturer
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