Device Recall Maquet Inc.

  • 모델명 / 제조번호(시리얼번호)
    (PN 0684-00-0294-01U) (PN 0684-00-0294-02U) (PN 0684-00-0295-01U) (PN 0684-00-0295-02U) (PN 0684-00-0296-01U)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ || MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    SN 00048
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Japan, Kuwait, Kazakhstan, Mexico, Netherlands, Norway, Russia, Sweden, Turkey, Taiwan and South Africa.
  • 제품 설명
    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot number 3000033848
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of : CA.
  • 제품 설명
    Custom Tubing Pack with Bioline Coating || UDI code: 00607567208230 || Part Number: 709000058 || The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
  • Manufacturer