PillSense Receiver

Basic Information

• Brand Name: PillSense Receiver
• Primary DI: 05391539210073
• Version / Model: P00167-01FP
• 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: 60a8601c-599c-4236-849b-75cb8250bf8d

Device 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”.

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
62386	Gastrointestinal telemetric monitoring system receiver	A portable, hand-held, electronic component of a gastrointestinal telemetric monitoring system designed to continuously and wirelessly receive electrical signals of gastrointestinal parameters (e.g., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from an ingested capsule (not included). It may incorporate a display or be connected to an off-the-shelf device (e.g., computer, printer) to display/print the acquired data; it may also have data recording/storage capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391539210073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN220065	000