Multiphze Enclosed Bladder Irrigation System

Basic Information

• Brand Name: Multiphze Enclosed Bladder Irrigation System
• Primary DI: 00860008304407
• Version / Model: 04190
• Company Name: Multiphze, LLC
• Labeler DUNS: 113899658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2023-01-13
• Public Version Status: Update
• Public Device Record Key: 2a94ca4c-9543-4d0c-b3cc-fc4eeef4b3c9

Device Description

The Multiphze Enclosed Bladder Irrigation System is a single-use, sterile, disposable device designed for use with an indwelling catheter for irrigation and/or drainage.

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: 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: 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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	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	00860008304407	GS1
Package	10860008304404	GS1	Shelf carton	10	In Commercial Distribution