Bio-Detek, Inc.

8 devices in the database

  • Model / Serial
    Lot Numbers: 1614, 1914, 2114
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • Product Description
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single || Part number: || 8900-4055-40 || 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.
  • Model / Serial
    Lot Numbers: 1614, 1814
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • Product Description
    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.
  • Model / Serial
    Lot Numbers: 1614, 1814, 1914
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • Product Description
    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) || Part Number: 8900-4012 || 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.
  • Model / Serial
    Lot #'s : 2108 & 2208
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA
  • Product Description
    ZOLL OneStep Multi-Function Electrode; Adult Complete || Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
  • Model / Serial
    Lot Number: 2314
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
  • Product Description
    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with || 10-ft (3 m) leadwires || Part number: 8900-4052 || These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.
3 more