FDA-Device2019-01-30Class II
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Stihler Electronic Gmbh
Hazard
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Sold states
Worldwide Distribution - US Nationwide in the states of CA and Foreign of: Switzerland
Affected count
821
Manufactured in
Julius-Holder-Str. 36, N/A, Stuttgart, N/A, Germany
Products
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0759-2019Don't want to check this manually?
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