Device Recall Portex First Breath ADULT Elongated NonRebreather Oxygen Mask with 1L Reservoir Bag & Tubing,

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  09-50  10-05  10-09  10-10  10-11  10-17
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
  • 제품 설명
    First Breath ¿ ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing, 213cm (7ft.) 50/CA || Reorder Number: 001431 || Oxygen/Aerosol Mask For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA