Identity
- Trade Name
- PillSense Receiver FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system receiver FDA UDI
- Device Name
- The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”. FDA UDI
- Model / Reference
- P00167-01FP FDA UDI
- Description
- The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391539210073 FDA UDI
- 510(k) Number
- DEN220065 FDA UDI
- FDA Product Code
- QUD FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system receiver 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 receiver
PillSense Receiver by Enterasense , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal telemetric monitoring system receiver.
- Atmo Biosciences — Atmo Biosciences, Ltd. · Class II
- Heidelberg pH Capsule System — Heidelberg Medical Inc · Class I
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 60a8601c-599c-4236-849b-75cb8250bf8d 35 fields · synced Jun 1, 2026