PillSense Receiver

Primary DI
05391539210073
Brand
PillSense Receiver
Company
ENTERASENSE LIMITED
Model
P00167-01FP
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”.
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QUDBlood Detection Capsule

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUDBlood Detection CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220065000Pill Sense SystemEnterasense , Ltd.2023-02-24QUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391539210073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391539210073053915392100735391539210073

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system receiverA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35391750246customerservice@enterasense.com

Regulatory Flags#

DUNS number
985620854
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391539210059PillSense CapsuleP00050-01FP2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391539210059PillSense CapsuleENTERASENSE LIMITEDQUD2023-06-26