FDA-Device2020-05-20Class II
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Edwards Lifesciences, LLC
Hazard
Intermittent communication due to inconsistent crimping of connectors onto cables.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
Affected count
35
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1928-2020Don't want to check this manually?
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