URIDRAIN Standard Male External Catheter

  • Modèle / numéro de série
    Lot Numbers: 030772764 109555264
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
  • Description du dispositif
    URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe || Product ID: 8884732000 || Intended use: Collector urine from male patients (and accessories) for indwelling catheter
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • 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

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
  • Description du dispositif
    URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe || Product ID: 8884732500 || Intended use: Collector urine from male patients (and accessories) for indwelling catheter
  • Manufacturer