Device typeTracheoesophageal device insertion capsule: A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.
FDA categoryProsthesis, Laryngeal (Taub)
Device ID00813307014508
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information