FDA UDI
In Commercial Distribution
🇺🇸 United States
MotiliCap GI Monitoring System Capsule
DI: 00810164590657
·
Model: CP-US-7010
·
ANX ROBOTICA CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MotiliCap GI Monitoring System Capsule
- Primary DI
- 00810164590657
- Version / Model
- CP-US-7010
- Catalog Number
- CP-US-7010
- 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
- d371d9ba-84b3-42e4-8179-7b48749e199b
Device Description
The MotiliCap capsule is used with the MotiliCap GI Monitoring System which monitors the GI tract for temperature, pressure, and pH to help physician determine the motility of a patient.
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 | 00810164590657 | GS1 |
Customer Contacts
- Phone
- 855-777-0020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250493 | 000 |