Device Recall Comfort and Comfort Short infusion setACCU Chek Tender Set

  • 모델명 / 제조번호(시리얼번호)
    5032433, 5033654, 5037164, 5040419, 5044362, 5046682, 5051308, 5053298, 5058508, 5061927, 5062202, 5065546, 5069297, 5072252, 5075118, 5044359, 5053289, 5061929, 5032436, 5033657, 5037159, 5040420, 5044355, 5046683, 5051309, 5053299, 5058501, 5061928, 5062205, 5065539, 5069295, 5072249, 5032442, 5033662, 5037162, 5040424, 5044361, 5051304, 5053292, 5058505, 5061931, 5061933, 5062208, 5032438, 5037160, 5044360, 5051310, 5053300, 5062211, 5069296, 5072253, 5032439, 5032440, 5033659, 5033660, 5037161, 5040422, 5044365, 5046684, 5051303, 5053297, 5058503, 5061939, 5062212, 5065550, 5065551, 5069298, 5072250, 5075121, 5032441, 5033661, 5037167, 5040423, 5044366, 5046681, 5051311, 5053293, 5058504, 5061930, 5065552, 5069301, 5072254, 5033658, 5044363, 5062206, 5062207, 5065540, 5065541, 5065542, 5069302, 5072251
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • 제품 설명
    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • 제조사 모회사 (2017)
  • Source
    USFDA