Device Recall Dexcom G4 PLATINUM (Professional) Receiver

  • 모델명 / 제조번호(시리얼번호)
    Receiver Kit Number: STK-PU-001  Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
  • 제품 설명
    Dexcom G4 PLATINUM (Professional) Receiver || Receiver Part Number: MT20649 Receiver (mg/dL), Black. || Intended to detect trends and track glucose patterns in persons with diabetes. || The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Dexcom Inc, 6340 Sequence Dr, San Diego CA 92121-4356
  • 제조사 모회사 (2017)
  • Source
    USFDA