Devices

Device Recall Safe Spot Infant Resuscitator

  • 모델명 / 제조번호(시리얼번호)
    Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IL, OH, NY and TN.
  • 제품 설명
    Safe Spot Infant Resuscitator, SS3200 Series, Single Patient 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
    Ventlab Corporation
  • 1 Event

제조사

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

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Device Recall Safe Spot Infant Resuscitator
  • 모델명 / 제조번호(시리얼번호)
    Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including IL, OH, NY and TN.
  • 제품 설명
    Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, || 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
    Ventlab Corporation