FDA-Device2013-10-09Class I
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
King Systems Corp.
Hazard
King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
Sold states
Nationwide Distribution - NE only.
Affected count
1 case; 40 units
Manufactured in
15011 Herriman Blvd, Noblesville, IN, United States
Products
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2272-2013Don't want to check this manually?
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