Devices

Device Recall AccuChek

  • 모델명 / 제조번호(시리얼번호)
    Lots 31037UF, 31053UF, 31074UF, 31103UF, 3C130UF, 3D055UF, 3F060UF, 3F061UF, 3F095UF, 3G052UF, 3G127UF, 3I153UF, 3J068UF, 3J163UF, 3K047UF, 3K126UF, 3L144UF, 4B033UF, 4D044UF, 4E014UF, 4E141UF, 4F051UF, 4G035UF, 4G050UF, 4H159UF, 4H234UF, 4I056UF, 4I195UF, 4J076UF, 4K016UF, 4K164UF, 5C042UF, 5D211UF, 5E005UF, 5F074UF, 5H097UF, 5I056UF, 5I132UF, 5J149UF, 5K024UF, 5K176UF and 6B108UF.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
  • 제품 설명
    Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the the U.S. only).
  • Manufacturer
    Disetronic Medical Systems, Inc.
  • 1 Event

제조사

Disetronic Medical Systems, Inc.
  • 제조사 주소
    Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 73 건

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Device Recall AccuChek Go
Device Recall AccuChek Aviva
  • 모델명 / 제조번호(시리얼번호)
    For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • 제품 설명
    Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek Aviva
  • 모델명 / 제조번호(시리얼번호)
    Aviva meter serial numbers 52500000000 through 52510999999.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • 제품 설명
    Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek Aviva
  • 모델명 / 제조번호(시리얼번호)
    Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • 제품 설명
    Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall AccuChek
  • 모델명 / 제조번호(시리얼번호)
    All lots.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
  • 제품 설명
    Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
  • Manufacturer
    Roche Diagnostics Corp.
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