SafeBreak - Vascular 2855-01-0001

GUDID 10860635000311

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.

Lineus Medical

Luer/Luer breakaway connector

• Primary Device ID: 10860635000311
• NIH Device Record Key: 6d68c13a-9967-417b-b8bf-4d1d8cb2b08a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeBreak - Vascular
• Version Model Number: A
• Catalog Number: 2855-01-0001
• Company DUNS: 081269269
• Company Name: Lineus Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10860635000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190043

FDA Product Code

• QOI: Intravenous Catheter Force-Activated Separation Device.

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

[10860635000311]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-28
• Device Publish Date: 2022-06-20