f070e5e0-f615-4159-b558-12ae452d5c4eUpdatePublished102024-11-152017-02-01In Commercial Distribution07290101366263PrimaryGS110884521726031Unit of UseGS1PillCamFGS-0585090073722Given Imaging, Inc.5UGI capsule, 5-packfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseMR Unsafetruefalse+1(508)261-8000covidien.udi@covidien.com38068Video capsule endoscopy system capsuleAn electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.falseActiveNEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULEStorage Environment TemperatureHandling Environment Temperaturefalsefalse