e•Sense 7Fr Abdominal Catheter

Basic Information

• Brand Name: e•Sense 7Fr Abdominal Catheter
• Primary DI: 00627825013567
• Version / Model: CATEA17
• Company Name: Laborie Medical Technologies Corp.
• Labeler DUNS: 117783313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-12
• Public Version: 1
• Public Version Date: 2024-12-20
• Public Version Status: New
• Public Device Record Key: 68c12536-df07-46db-8739-e8e2de39aef0

Device Description

e•Sense 7Fr Abdominal Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
62243	Urodynamic manometric catheter, electronic, single-use	A sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may have a lumen to fill/drain the bladder to facilitate pressure measurement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627825013567	GS1
Package	10627825013564	GS1		10	In Commercial Distribution
Package	20627825013561	GS1		100	In Commercial Distribution