TUR System

Basic Information

• Brand Name: TUR System
• Primary DI: 10887787006718
• Version / Model: 654202
• Catalog Number: 0654202
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Labeler DUNS: 830767898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 3
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: af9e91dd-f9c1-4adc-9041-629494a6cc68

Device Description

LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container Irrigation System (previously Hospira product)

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: Yes
• 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
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20887787006715	GS1	case	20	In Commercial Distribution
Primary	10887787006718	GS1
Secondary	M3356542020	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	2000	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature. Avoid Excessive Heat. Protect from Freezing