Nova Biomedical Corporation

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Description

12 dispositivos en la base de datos

  • Modelo / Serial
    Lot Numbers: 610633, 701034, 704053, 707222
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, USA, Canada, Argentina, Bangladesh, Bolivia, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,Germany,Greece, Hungary, India, Indonesia, Ireland,Italy, Japan, Korea, Mexico, Peru, Poland, Scotland, South Africa, Spain, Sri Lanka. Switzerland, Syria ,Taiwan, Turkey and The United Kingdom
  • Descripción del producto
    Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
  • Modelo / Serial
    Batteries coded: XX07 and earlier The Nova Biomedical products that contain the lithium batteries include the following part numbers: Part # 41772 - Battery Assy,  Part # 42215 - Battery Replacement pack,  Part # 42224 - Kit Meter,  Part # 43735 - Kit Meter EZ CHEM,  Part # 43773 - Kit Meter,  Part # 43811 - Battery Replacement Pack EZ CHEM,  Part # 44013 - Kit Meter,  Part # 44014 - Kit Meter and Part # 44251 - Kit Meter.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada, Taiwan, Hungary, Malaysia, Australia, Russia, Thailand, New Zealand, Austria, France, Germany, UK, China, South Africa, Croatian, Peru, and Czech Republic.
  • Descripción del producto
    Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) || Used with: || Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.
  • Modelo / Serial
    Lots 806050, 806182, 806242, 806567, 806721, 806752, and 807246.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.
  • Descripción del producto
    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer || Catalog # 35238 || Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.
  • Modelo / Serial
    Version 4.08
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI
  • Descripción del producto
    CCX Operating Software , Version 4.08
  • Modelo / Serial
    All S/N''s
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI
  • Descripción del producto
    Stat Profile Critical Care PLUS (CCX) Analyzer || Catalog Number: 37413
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Más información acerca de la data acá

  • Dirección del fabricante
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
2 más