Device typeGastrointestinal telemetric monitoring system capsule, ingestible: A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.
FDA categoryIngestible Event Marker
Device ID00857335005114
Catalog numberSPC-2731
AvailabilityPrescription
Single useYes
MRI safetyMR Unsafe
Length113.2 Millimeter
Width45.2 Millimeter
Height6.9 Millimeter
Area/Surface Area32.1 Square centimeter