PillSense Receiver

GUDID 05391539210073

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”.

ENTERASENSE LIMITED

Gastrointestinal telemetric monitoring system receiver

• Primary Device ID: 05391539210073
• NIH Device Record Key: 60a8601c-599c-4236-849b-75cb8250bf8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PillSense Receiver
• Version Model Number: P00167-01FP
• 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

Customer Support Contacts

• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com
• Phone: +35391750246
• Email: customerservice@enterasense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391539210073 [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: 2023-07-04 The PillSense Capsule (11x27mm) is a single patient use device which features an optical sensor which detects blood and wireless
• 05391539210073 - PillSense Receiver: 2023-07-04The 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”.
• 05391539210073 - PillSense Receiver: 2023-07-04 The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver int