Multiphze Enclosed Bladder Irrigation System

FDA UDI

Class II (US FDA UDI)

by Multiphze, LLC

Identity

Trade Name: Multiphze Enclosed Bladder Irrigation System FDA UDI
Generic Name: Urological irrigation set FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 04190 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860008304407 FDA UDI
FDA Product Code: KNX FDA UDI
GMDN Term: Urological irrigation set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urological irrigation set

Multiphze Enclosed Bladder Irrigation System by Multiphze, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Multiphze, LLC

Sources (1)

FDA UDI 2a94ca4c-9543-4d0c-b3cc-fc4eeef4b3c9 33 fields · synced May 31, 2026