Devices

One Touch Ultra Test Strips

  • 모델명 / 제조번호(시리얼번호)
    Lot number 2829235
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including Puerto Rico.
  • 제품 설명
    One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. || Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
  • Manufacturer
    Lifescan Inc
  • 1 Event

제조사

Lifescan Inc
  • 제조사 주소
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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Device Recall One Touch Ultra Test Strips
  • 모델명 / 제조번호(시리얼번호)
    Part Number 020-245-32, lot number 2964512, manufactured between 09/10/2009 and 09/24/2009, distributed between 09/30/2009 and 10/27/2009.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.
  • 제품 설명
    One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
  • Manufacturer
    Lifescan Inc
One Touch Ultra test strips
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 2691191
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution --- States of CA, TX, TN, GA, AL, and OK
  • 제품 설명
    One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips
  • Manufacturer
    Discount Diabetic Supply