TruCath

Basic Information

• Brand Name: TruCath
• Primary DI: 00851809002531
• Version / Model: CK12
• Catalog Number: CK12
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-20
• Public Version: 3
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 7d7a44ed-98d5-436c-8c58-f141ec60daae

Device Description

TruCath Closed System Catheter Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
KOD	Catheter, Urological	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	50851809002536	GS1	Case	100	In Commercial Distribution
Primary	00851809002531	GS1

Customer Contacts

• Phone: [phone] ext. 110
• Email: [email protected]