EZ-Advancer

Basic Information

• Brand Name: EZ-Advancer
• Primary DI: 00850058254777
• Version / Model: AKS14
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-11
• Public Version: 1
• Public Version Date: 2025-08-19
• Public Version Status: New
• Public Device Record Key: 5a7bf88e-1890-4410-8959-8f1436da7f1d

Device Description

EZ-Advancer® Closed System Intermittent Catheter Kit

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
KOD	Catheter, Urological	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45605	Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50850058254772	GS1	Case	20	In Commercial Distribution
Primary	00850058254777	GS1

Customer Contacts

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