CareLink iPro

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to TN, MN, and WA
  • 제품 설명
    CareLink iPro Version 1.10, Catalog No. MMT-7340 || With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Inc., 18000 Devonshire Street, Northridge CA 91325-1219
  • 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 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All Serial# for (model: MMT-7340)
  • 제품 설명
    Glucose monitoring system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    MMT-7340 | All | 1.12
  • 제품 설명
    MD: Percutaneous glucose monitoring system
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Version 1.12
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution
  • 제품 설명
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 || The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose sensor data stored on a recording device, capture BG meter readings through manual entry or wired-upload, retrospectively calibrate sensor data, and provide retrospective reports of continuous glucose information. The reports generated by the CareLink iPro software are intended for use by healthcare professionals to assist with diabetes clinical assessment, patient education, and therapy optimization.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    CareLink iPro Therapy Management Software MMT-7340ARTG Number: 133091
  • Manufacturer