Devices

Device Recall STATCheck

  • 모델명 / 제조번호(시리얼번호)
    Model #SC9000B, Lot #4034-10, 4047-07, 4064-10; Model #SC9000C, Lot #3295-03; Model #SC9001B, Lot #3290-03, 3309-22, 4047-05, 4064-11, 4071-13; Model #SC9001C, Lot #3290-04,3309-24, 3349-05, 4034-04.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA
  • 제품 설명
    STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO¿ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
  • Manufacturer
    Ventlab Corporation
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

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Device Recall STATCheck
  • 모델명 / 제조번호(시리얼번호)
    Model SC9001B Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot numbers 303320 and 303612  Model SC9001C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask Lot number 303400  Model SC9001C-C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector Lot numbers 303523 and 303791  Model SC8001B Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot number 303833
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
  • 제품 설명
    STAT-Check Resuscitation Bag || Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer || Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
  • Manufacturer
    Ventlab LLC
Device Recall STATCheck MANUAL RESUSCITATOR / VENTILATOR
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 313406, 313447, 313164, 313165 & 313166
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    IL & OH distributors
  • 제품 설명
    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
  • Manufacturer
    Sun Med, LLC
Device Recall STATCheck
  • 모델명 / 제조번호(시리얼번호)
    Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA
  • 제품 설명
    STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO¿ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
  • Manufacturer
    Ventlab Corporation
Device Recall STATCheck
  • 모델명 / 제조번호(시리얼번호)
    Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05, 4056-05, 4063-07, 4064-20, 4078-03
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA
  • 제품 설명
    A.C.E. STAT-Check CO¿ Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028
  • Manufacturer
    Ventlab Corporation
Device Recall STATCheck
  • 모델명 / 제조번호(시리얼번호)
    Model #SC7000B, Lot #4047-08
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA
  • 제품 설명
    STAT-Check Infant Disposable Manual Resuscitators, with 40 cmH¿O Pressure Limiting System & Pressure Port Adapter, Single Patient Use Non-Sterile, Re-Order SC7000 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX
  • Manufacturer
    Ventlab Corporation
하나 더 2 건 더