Device Recall Breath Tech, Safe Spot Infant Resuscitator

  • 모델명 / 제조번호(시리얼번호)
    Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IL, OH, NY and TN.
  • 제품 설명
    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. || The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
  • Source
    USFDA