Perfusion tubing Set

  • 모델명 / 제조번호(시리얼번호)
    Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346,  209704347,210010558    TL7M64R3 209789393 TL7P17R1 209789333
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including US: AL, IL, IN, and WI.
  • 제품 설명
    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. || The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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 24 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 1010400032, 1015800061, 1016500044, 1017300020, 1022100041, 1022900026
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • 제품 설명
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 1020100025
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • 제품 설명
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 1024400046
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • 제품 설명
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
하나 더 19 건 더