Identity
- Trade Name
- PillSense Capsule FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- P00050-01FP FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391539210059 FDA UDI
- 510(k) Number
- DEN220065 FDA UDI
- FDA Product Code
- QUD FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Gastrointestinal telemetric monitoring system capsule, ingestible
PillSense Capsule by Enterasense , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN220065 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Enterasense , Ltd.
Sources (1)
- FDA UDI 0709fe40-8428-4528-8a4a-7ae4bb83d3cb 34 fields · synced May 31, 2026