capsule, 5-pack

capsule, 5
SmartPill - FGS-0503

An assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NYV

Device Name: Gastrointestinal Motility System, Capsule

Device Class: 2

Physical State: Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.

Definition: Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Device is swallowed, and passes through the GI tract

Regulation Number: 876.1725

Third Party Flag: N

Medical Specialty: GU

Device Id: 04260167482682

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10884521726147

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A