CareLink iPro

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to TN, MN, and WA
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Medtronic Inc., 18000 Devonshire Street, Northridge CA 91325-1219
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    All Serial# for (model: MMT-7340)
  • Description du dispositif
    Glucose monitoring system
  • Manufacturer
  • Modèle / numéro de série
  • Manufacturer
  • Modèle / numéro de série
    MMT-7340 | All | 1.12
  • Description du dispositif
    MD: Percutaneous glucose monitoring system
  • Manufacturer
  • Modèle / numéro de série
    Version 1.12
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution
  • Description du dispositif
    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