AccessGUDID - DEVICE: PillSense Capsule (05391539210059)

GUDID

Device Identifier (DI) Information

Brand Name: PillSense Capsule
Version or Model: P00050-01FP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENTERASENSE LIMITED

Primary DI Number: 05391539210059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985620854 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62385	Gastrointestinal telemetric monitoring system capsule, ingestible	A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QUD	Blood Detection Capsule

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220065	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0709fe40-8428-4528-8a4a-7ae4bb83d3cb
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023