Devices

Device Recall STATCheck

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA
  • Description du dispositif
    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

Fabricant

Ventlab Corporation
  • Adresse du fabricant
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028
  • Source
    USFDA

7 dispositifs médicaux avec un nom similaire

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Device Recall STATCheck
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot Numbers: 313406, 313447, 313164, 313165 & 313166
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    IL & OH distributors
  • Description du dispositif
    STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1
  • Manufacturer
    Sun Med, LLC
Device Recall STATCheck
  • Modèle / numéro de série
    Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA
  • Description du dispositif
    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
  • Modèle / numéro de série
    Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05, 4056-05, 4063-07, 4064-20, 4078-03
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA
  • Description du dispositif
    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
  • Modèle / numéro de série
    Model #SC7000B, Lot #4047-08
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA
  • Description du dispositif
    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
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