Device Recall MEDICYCLE Lite Portable Oxygen System

  • 모델명 / 제조번호(시리얼번호)
    Model : Manufacturer's #M70500037 Cataogue Number: 109855   Lot numbers:  25/07 48/06 20/03
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    MEDICYCL-E- Lite Portable Oxygen System || An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Linde Gas North America Llc, 575 Mountain Ave, Attn Import Compliance Manager, New Providence NJ 07974
  • 제조사 모회사 (2017)
  • Source
    USFDA