Radiometer America Inc

14 dispositivos en la base de datos

  • Modelo / Serial
    Model number 393-090 (instrument).  The affected analyzers are serial numbers 393-090R0027N001 to present.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovenia, United Arab Emirates, Bolivia, Brazil, Indonesia, Israel, Kuwait, Malaysia, Mexico, Peru, Qatar, Saudi Arabia, Serbia and Montenegro, Syrian Arab Republic, Thailand, Vietnam, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Republic of Korea, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
  • Modelo / Serial
    Part Number: 945-655, Lot Code: DP-06
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.
  • Descripción del producto
    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. || Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).
  • Modelo / Serial
    S1827 Part Number: 944-135, lot DV02
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) including the states of: NY, PA and TN.
  • Descripción del producto
    S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark || Product Usage: || The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.
  • Descripción del producto
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: || -Samples of whole blood for the parameters pH, pO2, pCO2, || cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) || -Samples of expired air for the parameters pO2 and pCO2 || -Pleura samples for the pH parameter. || The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
  • Modelo / Serial
    ABL725: 441R0086N008, 441R0292N010, and 441R0520N009U  ABL 735: 441R0050N001, 441R0231N0009, 441R0234N0010, 441R0292N0009, 441R0303N010, 441R0340N004, 441R0343N010, and 441R0522N008
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.
  • Descripción del producto
    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: || -Samples of whole blood for the parameters pH, pO2, pCO2, || cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) || -Samples of expired air for the parameters pO2 and pCO2 || -Pleura samples for the pH parameter. || The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
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Más información acerca de la data acá

  • Dirección del fabricante
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA
  • Empresa matriz del fabricante (2017)
  • Representante del fabricante
    Salehiya Trading Est.
  • Source
    SFDA
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA