e∙Sense

Basic Information

• Brand Name: e∙Sense
• Primary DI: 08718122028339
• Version / Model: Bladder & Urethral Dual Sensor Catheter, straight tip shape
• Catalog Number: 37042005
• Company Name: PendraCare International B.V.
• Labeler DUNS: 413008652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4aed7935-d92f-4efe-b2eb-d0b33dd76f98

Device Description

e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55837	Urodynamic catheter	A long, thin, sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for urodynamic examination of a patient. It is inserted into the bladder via the urethra or non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output, and for urethral pressure and other urethral and voiding pressure examinations. It is available with various lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08718122028339	GS1
Package	38718122028330	GS1	Carton box	10	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter
Device Size Text, specify			7F Diameter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight.
• Type: Special Storage Condition, Specify
• Special Conditions: keep dry