Device Recall N PROT CONTROL SL/L, SL/M, SL/H

  • 모델명 / 제조번호(시리얼번호)
    SMN 10446079: Lot (UDI): 084647A (00842768016127084647A20170913), 084647C (00842768016127084647C20170913) exp. date 2017-09-13; 084648(0084276801612708464820180430),  084648C (00842768016127084648C20180430),  084648H (00842768016127084648H20180430), exp. date 2018-04-30. --- SMN 10446085: Lot (UDI): 084749D (00842768016134084749D20170917) exp. date 2017-09-17; 084750 (03 0084276801613408475020180203),  084750B (00842768016134084750B20180203), 084750E (00842768016134084750E20180203) exp. date 2018-02-03. --- SMN 10446089: Lot (UDI) 084847A (00842768016110084847A20170613),  084847B (00842768016110084847B20170613) exp. date 2017-06-13; 084848A (00842768016110084848A20171217),  084848D (00842768016110084848D20171217),  084848E (00842768016110084848E20171217),  084848H (00842768016110084848H20171217),  084848L (00842768016110084848L20171217) exp. date 2017-12-17;  084849 (0084276801611008484920180704),  084849C (00842768016110084849C20180704), 084849D (00842768016110084849D20180704) 084849E (00842768016110084849E20180704) exp. date 2018-07-04.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,
  • 제품 설명
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA