Ventlab LLC

  • Adresse du fabricant
    Ventlab LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Société-mère du fabricant (2017)
  • Source
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

  • 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
  • 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.).

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  • Adresse du fabricant
    Ventlab LLC, 2710 Northridge Dr Nw, Suite A, Grand Rapids MI 49544-9112
  • Société-mère du fabricant (2017)
  • Source
    USFDA