URO Saf-Gard Extension Tubing

Basic Information

• Brand Name: URO Saf-Gard Extension Tubing
• Primary DI: 00868636000401
• Version / Model: 18 inch
• Catalog Number: UROET18
• Company Name: URO CONCEPTS INC
• Labeler DUNS: 169168882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-03
• Public Version: 1
• Public Version Date: 2019-08-12
• Public Version Status: New
• Public Device Record Key: 86582283-a03e-499d-81e8-ee9a4d7ddaeb

Device Description

18 “Tubing

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
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	876.5250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47459	Urine monitoring system collector	A sterile receptacle (e.g., a bag) designed to collect a patient's urine as part of a urine monitoring system. It is connected with tubing to the patient's indwelling catheter and is in contact with the system's urine output sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868636000401	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 32 – 120 Degrees Fahrenheit