Palindrome SI Chronic Catheter Kit

제조사

  • 제조사 주소
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 8888145048 8888145048C 8888145048CP 8888145049 8888145049C 8888145049CP 8888145050 8888145050C 8888145050CP 8888145057 8888145057C 8888145057CP 8888145062 8888145063 8888145066 8888145066C
  • 제품 설명
    Inactive implantable medical devices
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item codes identified with an expiry date of February 2018 and earlier
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
  • 제품 설명
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm || Item Code: 8888145065C
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8888145066 (Lot serial: >10 lots); Model Catalog: 8888145065 (Lot serial: >10 lots); Model Catalog: 8888145064 (Lot serial: >10 lots); Model Catalog: 8888145063 (Lot serial: >10 lots); Model Catalog: 8888145062 (Lot serial: >10 lots); Model Catalog: 8888145048 (Lot serial: >10 lots); Model Catalog: 8888145049 (Lot serial: >10 lots); Model Catalog: 8888145050 (Lot serial: >10 lots); Model Catalog: 8888145057 (Lot serial: >10 lots); Model Catalog: 8888133508 (Lot serial: >10 lots); Model Catalog: 8888119368 (Lot serial: >10 lots); Model Catalog: 8888123408 (Lot serial: >10 lots); Model Catalog: 8888128458 (Lot serial: >10 lots); Model Catalog: 8888133509 (Lot serial: >10 lots); Model Catalog: 8888119369 (Lot serial: >10 lots); Model Catalog: 8888123409 (Lot serial: >10 lots); Model Catalog: 8888128459 (Lot serial: >10 lots)
  • 제품 설명
    PALINDROME SI CHRONIC CATHETER KIT
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8888145042 (Lot serial: 1435800009); Model Catalog: 8888145042 (Lot serial: 1431900098); Model Catalog: 8888145042 (Lot serial: 1503500094)
  • 제품 설명
    PALINDROME SI CHRONIC CATHETER KIT
  • Manufacturer