Multiphze Enclosed Bladder Irrigation System

GUDID 00860008304407

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.

Multiphze, LLC

Urological irrigation set

• Primary Device ID: 00860008304407
• NIH Device Record Key: 2a94ca4c-9543-4d0c-b3cc-fc4eeef4b3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multiphze Enclosed Bladder Irrigation System
• Version Model Number: 04190
• Company DUNS: 113899658
• Company Name: Multiphze, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008304407 [Primary]
GS1	10860008304404 [Package]; Package: Shelf carton [10 Units]; In Commercial Distribution

FDA Product Code

• KNX: Collector, Urine, (And Accessories) For Indwelling Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30