Bio-Detek, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 8 건

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1614, 1914, 2114
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1614, 1814
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1614, 1814, 1914
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Canada, Belgium, France, and Germany.
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Lot #'s : 2108 & 2208
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    MA
  • 제품 설명
    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.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 2314
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
  • 제품 설명
    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.
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