Zoll

  • Modèle / numéro de série
    Lot Numbers: 1614, 1814
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • Description du dispositif
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. || Part number: 8900-4013 || Product Usage: || These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Detek, Inc., 525 Narragansett Park Dr, Pawtucket RI 02861-4323
  • Source
    USFDA

56 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    SERIE M and SERIE R
  • Description du dispositif
    This product combines a defibrillator with advanced capabilities of ECG monitors and non-invasive transcutaneous rhythm (NTP) with communication, data printing and recording capabilities, designed to support cardiopulmonary resuscitation.
  • Manufacturer
  • Modèle / numéro de série
    8900-3000-01 and 8900-3001-01, lot 1615, referring to patient electrodes manufactured in April 2015.
  • Description du dispositif
    This product combines a defibrillator with advanced capabilities of ECG monitors and non-invasive transcutaneous rhythm (NTP) with communication, data printing and recording capabilities, designed to support cardiopulmonary resuscitation.
  • Manufacturer
  • Modèle / numéro de série
    M SERIES and R SERIES with End Tidal CO2 option (EtCO2)
  • Description du dispositif
    Indicated for resuscitation by defibrillation. The ZOLl defibrillators combine the functions of defibrillator, ECG visualization, advanced monitoring and non-invasive transcutaneous stimulation (NTP) with communication.
  • Manufacturer
  • Modèle / numéro de série
    UNI-VENT 731 EMV SERIES, software version 05.20.00
  • Description du dispositif
    This equipment provides ventilatory support to patients with some type of respiratory disease that must be moved from one place to another.
  • Manufacturer
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