TITAN HDTITAN HD

Basic Information

• Brand Name: TITAN HDTITAN HD
• Primary DI: 00884908145014
• Version / Model: DTHD155124
• Catalog Number: DTHD155124
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-24
• Public Version: 4
• Public Version Date: 2022-07-11
• Public Version Status: Update
• Public Device Record Key: 49186f13-78df-48b3-b19c-6f195123caf8

Device Description

15.5F X 24CM TITAN HD15.5F X 24C CATHETER WITH SIDEHOLESCATHETER (CUFF 19CM FROM TIP)(CUFF 19CM F (CATHETER ONLY)(CATHETER ONLY)

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
MSD	Catheter, hemodialysis, implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908145019	GS1	box	10	Not in Commercial Distribution	2021-08-23
Primary	00884908145014	GS1

Customer Contacts

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