Glucose

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA

559 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Number: 0309019249, Expiration Date: 1/31/2011.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
  • Descripción del producto
    Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. || Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.
  • Manufacturer
  • Modelo / Serial
    Serial numbers - see word document in supporting info
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
  • Descripción del producto
    One Touch Ping Glucose Management Systems || Intended use: deliver insulin therapy
  • Manufacturer
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, || Rechargeable Lithium Batteries || Single: 46626; 4 Pack: 46827; 5 Pack: 50436. || For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
  • Manufacturer
  • Modelo / Serial
    Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
  • Descripción del producto
    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. || Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
  • Manufacturer
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