MotiliCap GI Monitoring System Mobile Phone/App

Basic Information

• Brand Name: MotiliCap GI Monitoring System Mobile Phone/App
• Primary DI: 00810164590817
• Version / Model: MO-US-8010
• Catalog Number: MO-US-8010
• Company Name: ANX ROBOTICA CORP
• Labeler DUNS: 024972857
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-09
• Public Version: 1
• Public Version Date: 2026-02-17
• Public Version Status: New
• Public Device Record Key: cec46fd5-ab40-46b0-90d1-0e48517c4ba1

Device Description

The MotiliCap Phone is used with the MotiliCap GI Monitoring System for the patient to record specified events during the procedure that will be incorporated into the final data analysis through MotiliScan.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYV	Gastrointestinal Motility System, Capsule	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58357	Gastrointestinal telemetric monitoring system	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810164590817	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250493	000