PillSense Capsule

GUDID 05391539210059

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.

ENTERASENSE LIMITED

Gastrointestinal telemetric monitoring system capsule, ingestible

• Primary Device ID: 05391539210059
• NIH Device Record Key: 0709fe40-8428-4528-8a4a-7ae4bb83d3cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PillSense Capsule
• Version Model Number: P00050-01FP
• Company DUNS: 985620854
• Company Name: ENTERASENSE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391539210059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220065

FDA Product Code

• QUD: Blood Detection Capsule

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by ENTERASENSE LIMITED

• 05391539210059 - PillSense Capsule: 2023-07-04The 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.
• 05391539210059 - PillSense Capsule: 2023-07-04 The PillSense Capsule (11x27mm) is a single patient use device which features an optical sensor which detects blood and wireless
• 05391539210073 - PillSense Receiver: 2023-07-04 The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver int