Tru-Fix Catheter Fixation Kit

Basic Information

• Brand Name: Tru-Fix Catheter Fixation Kit
• Primary DI: H862TFK080
• Version / Model: TFK-08
• Catalog Number: TFK-08
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 6
• Public Version Date: 2022-05-13
• Public Version Status: Update
• Public Device Record Key: ce42a0ac-bd29-4306-a22f-6fae6ea338cc
• Distribution End Date: 2026-06-30

Device Description

Tru-Fix Catheter Fixation Kit - 8F

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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56631	Wearable percutaneous catheter/tube holder	A device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may additionally be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include a transparent film portion intended for fixation site monitoring. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H862TFK082	HIBCC	Shipper	5	In Commercial Distribution	2026-06-30
Package	H862TFK081	HIBCC	Dispenser	5	Not in Commercial Distribution	2026-06-30
Primary	H862TFK080	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	8	French