Cook, Inc.

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Description

284 dispositivos en la base de datos

  • Modelo / Serial
    Part number: C-UTLMY-901J-RSC-ABRM-IHI-HC-FST-A-RD, Global part number G51590.   Lot numbers: 2310844, 2310846, 2310948, 2310855, 2310873, 2311602, F2336773.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Descripción del producto
    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, C-UTLMY-901J-RSC-ABRM-HC-IHI-FST-A-RD, G51590, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Modelo / Serial
    Part number: C-UTLMY-901J-LSC-ABRM-HC-FST-A-RD, Global part number G51588.   Lot numbers: F2368896, F2371431.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Descripción del producto
    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 25 cm, C-UTLMY-901J-LSC-ABRM-HC-FST-A-RD, G51588, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Modelo / Serial
    Part number: C-UTLMY-901J-RSC-ABRM-HC-FST-A-RD, Global part number G51587.   Lot numbers: 2245788, 2256873, 2270656, 2271261, 2279156, 2290126, 2312063, 2318704, 2322407, 2326671, 2328388, 2331444, 2331447.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Descripción del producto
    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, C-UTLMY-901J-RSC-ABRM-HC-FST-A-RD, G51587, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Modelo / Serial
    Part number: C-UTLMY-901J-ABRM-HC-FST-A-RD, Global part number G51586.   Lot numbers: 2250305, 2266445, 2266451, 2266468, 2275433, 2275442, 2275470, 2287305, 2287306, 2287309, 2312039, 2315321, 2324248, 2324252.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Descripción del producto
    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, C-UTLMY-901J-ABRM-HC-FST-A-RD, G51586, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
  • Modelo / Serial
    Part number: C-UTLMY-901J-ABRM-HC-FST-RD, Global part number G51585.   Lot numbers: 2262186, 2266446, 2287307, 2297816, 2310872, 2327422.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
  • Descripción del producto
    Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, C-UTLMY-901J-ABRM-HC-FST-RD, G51585, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
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Más información acerca de la data acá

  • Dirección del fabricante
    Cook, Inc., 750 Daniels Way, P.O. Box 489, Bloomington IN 47402-0489
  • Source
    USFDA
  • Comentario del fabricante
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Dirección del fabricante
    Cook, Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
    MHM