Radiometer America Inc

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 6 건

  • 모델명 / 제조번호(시리얼번호)
    P/N S1720, 944-024; Lot: WA-04
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
  • 제품 설명
    ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 || Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 393-090, all production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.
  • 제품 설명
    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. || The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • 모델명 / 제조번호(시리얼번호)
    S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
  • 제품 설명
    ABL90 FLEX Blood Analyzer Part Number: 393-090. || Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 942-058, Article Number: D711
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
  • 제품 설명
    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers:  942-046, all lot numbers between 319 and 325  942-060, all lot numbers between 159 and 252
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, and Venezuela.
  • 제품 설명
    Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. || Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).
하나 더 1 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA