FDA-Device2014-09-24Class II
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.
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
100 cases =600 units
Manufactured in
525 Narragansett Park Dr, N/A, Pawtucket, RI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2660-2014Don't want to check this manually?
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