Heartport

  • Modelo / Serial
    Product Code DFK24 Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy.
  • Descripción del producto
    Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

9 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers 020349, 050327, 060337.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers 020347, 030343, 060338, 080348
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
  • Manufacturer
  • Modelo / Serial
    Lot Numbers 010367, 020342, 020378, 020379, 020380, 030353, 060358.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT System, Product codes ED241, 242, 243, 244.
  • Manufacturer
  • Modelo / Serial
    Lot numbers 030356, 050347, 060359.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24.
  • Manufacturer
  • Modelo / Serial
    Lot number 020374
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
  • Manufacturer
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