Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10193489100273
• Version / Model: URO10441
• Catalog Number: URO10441
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: 75edbaad-a9e2-4359-8c27-38c4902f09b6

Device Description

KIT,CATH,SELF,MY-CATH,TOUCH-FREE,14FR

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: No
• 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
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47778	Intermittent urethral catheterization kit	A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20193489100270	GS1	CASE	60	In Commercial Distribution
Primary	10193489100273	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store product away from direct exposure to light at room temperature.