PillSense Capsule
Basic Information
- Brand Name
- PillSense Capsule
- Primary DI
- 05391539210059
- Version / Model
- P00050-01FP
- Company Name
- ENTERASENSE LIMITED
- Labeler DUNS
- 985620854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-26
- Public Version
- 1
- Public Version Date
- 2023-07-04
- Public Version Status
- New
- Public Device Record Key
- 0709fe40-8428-4528-8a4a-7ae4bb83d3cb
Device Description
The PillSense Capsule (11x27mm) is a single patient use device which features an optical sensor which detects blood and wirelessly transmits data to the battery powered PillSense Receiver. The optical sensor contained in the PillSense Capsule detects the presence of liquid blood and/or hematin by analyzing the absorption of multiple wavelengths of light of the environment in which it is immersed. The data are then processed by an algorithm to determine if blood is present. The PillSense System has been validated to detect clinically relevant amounts of blood to as low as 5% blood in gastric contents. The capsule is designed to withstand the mechanical forces and chemical environment of the digestive system. After ingestion, the PillSense Capsule will make its way through the GI tract and is then passed naturally from the body.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QUD | Blood Detection Capsule | Gastroenterology, Urology | 876.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62385 | Gastrointestinal telemetric monitoring system capsule, ingestible | A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391539210059 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220065 | 000 |