AccessGUDID - DEVICE: Multiphze Enclosed Bladder Irrigation System (00860008304407)

GUDID

Device Identifier (DI) Information

Brand Name: Multiphze Enclosed Bladder Irrigation System
Version or Model: 04190
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Multiphze, LLC

Primary DI Number: 00860008304407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113899658 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2a94ca4c-9543-4d0c-b3cc-fc4eeef4b3c9
Public Version Date: January 13, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022