Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
US Nationwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2023