FDA-Device2014-09-24Class II
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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, cardioversi
Bio-Detek, Inc.
Hazard
Sterility of device is not assured
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, and Germany.
Affected count
12 each
Manufactured in
525 Narragansett Park Dr, N/A, Pawtucket, RI, United States
Products
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e 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. These MFE electrodes have a 12 month shelf life from time of manufacture.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2659-2014Don't want to check this manually?
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