Mediplus

Basic Information

• Brand Name: Mediplus
• Primary DI: 05055140702296
• Version / Model: 5806
• Company Name: MEDIPLUS LTD
• Labeler DUNS: 228480810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ccc2421f-b0cc-4cac-9393-9568d5fb8aff

Device Description

Pump tube set for urodynamics system - Laborie

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: Yes
• 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
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43415	Urological irrigation system	An assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15055140702293	GS1		25	In Commercial Distribution
Primary	05055140702296	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	3.75	Meter