FDA-Device2019-08-14Class II
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
SenTec AG
Hazard
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Sold states
Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.
Affected count
10 pcs
Manufactured in
Ringstrasse 39, N/A, Therwil, N/A, Switzerland
Products
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2154-2019Don't want to check this manually?
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