FDA UDI
In Commercial Distribution
🇺🇸 United States
MotiliCap GI Monitoring System Software (MotiliScan)
DI: 00810164590640
·
Model: MO-US-8005
·
ANX ROBOTICA CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MotiliCap GI Monitoring System Software (MotiliScan)
- Primary DI
- 00810164590640
- Version / Model
- MO-US-8005
- Catalog Number
- MO-US-8005
- 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
- 0123f104-a48a-4ca2-9af9-dce811804cb2
Device Description
The MotilCap Software (MotiliScan) is used with the MotiliCap GI monitoring system to record and analysis GI tract transit times for the physician analysis.
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 | 00810164590640 | GS1 |
Customer Contacts
- Phone
- 855-777-0020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250493 | 000 |