Covidien

  • Modèle / numéro de série
    Lot Numbers: 1508200108
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm || Item Code: 8888135137 || Product Usage: || Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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

259 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model # 10007101; Lot # 14A0041IN
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Description du dispositif
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • Modèle / numéro de série
    Model # 10116080 ; Lot # PO643063
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
  • Description du dispositif
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. || The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Pennine Healthcare: Covidien Devon Light Glove
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Covidien: Covidien Curity™ All Purpose Gauze Sponges, Curity™ X-Ray Detectable Laparotomy Sponges, Kerlix™ X-Ray Detectable Laparotomy Sponges, Vistec™ X-Ray Detectable Sponges
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Covidien: Covidien Curity™ Sodium Chloride Dressing; Covidien Curity™ Eye Pad Oval
  • Manufacturer
254 en plus