MED-RX

Basic Information

• Brand Name: MED-RX
• Primary DI: 00628725001012
• Version / Model: 10-3001
• Catalog Number: 10-3001
• Company Name: Canadian Hospital Specialties Limited
• Labeler DUNS: 240992693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-19
• Public Version: 4
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 6015e6a2-237c-4b61-91ff-185330c98554

Device Description

MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
LJH	System, Irrigation, Urological	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14301	Urological irrigation set	A collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628725001012	GS1
Package	50628725001017	GS1	CORRUGATE CASE	50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]