Baxter

Fabricante

  • Dirección del fabricante
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA

318 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product Code: 506005078050 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078051 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078052 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078058 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078060 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078070 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017  Product Code:506005078072 Lot #: All Expiration Date: August 01, 2015 - July 29, 2017
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
  • Descripción del producto
    Actifuse ABX/Actifuse MIS System || A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
  • Manufacturer
  • Modelo / Serial
    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Natiowide, Puerto Rico and Canada
  • Descripción del producto
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
  • Manufacturer
  • Modelo / Serial
    All serial numbers manufactured from 11/1/2005 to 4/22/2013, with release dates 1/1/2005 and forward.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Descripción del producto
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB || Product Usage: || The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
  • Manufacturer
  • Modelo / Serial
    All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Descripción del producto
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 || Product Usage: || The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
  • Manufacturer
  • Modelo / Serial
    All lot numbers in current distribution are under recall.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    The following brand name labeled products are under recall (all || catalog numbers and all lot numbers under recall): || NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula || Set and EXEL Secure Touch Safety AV Fistula Needle Set.
  • Manufacturer
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