SafeBreak - Vascular

Basic Information

• Brand Name: SafeBreak - Vascular
• Primary DI: 10860635000311
• Version / Model: A
• Catalog Number: 2855-01-0001
• Company Name: Lineus Medical
• Labeler DUNS: 081269269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 1
• Public Version Date: 2022-06-28
• Public Version Status: New
• Public Device Record Key: 6d68c13a-9967-417b-b8bf-4d1d8cb2b08a

Device Description

SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	880.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66263	Luer/Luer breakaway connector	A small, non-powered, noninvasive, linear Luer connector intended to connect an intravenous (IV) line to a peripheral catheter/cannula during IV administration, and to facilitate safe disconnection if excessive tension is placed on the IV line (e.g., unintentional tugging or pulling). The safe disconnection feature, which is sometimes referred to as a force activated separation mechanism and designed to reduce patient injury, includes valves to prevent blood loss, contamination, and IV fluid leakage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860635000311	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN190043	000