7ce1bfa7-1126-486b-aa32-e00bdf985352UpdatePublished52023-10-162021-03-122021-03-12Not in Commercial Distribution14897106950208PackageGS104897106950201202021-03-12Not in Commercial DistributionBox04897106950201PrimaryGS124897106950205PackageGS114897106950208102021-03-12Not in Commercial DistributionCartonandorate® CO2 Extend Tubing with Luer ConnectorGAR091686908512GA Health Company Limited1falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK20038800060738Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.falseActiveFCXInsufflator, Automatic Carbon-Dioxide For Endoscopefalsefalse