SafeBreak - Vascular

Primary DI
10860635000311
Brand
SafeBreak - Vascular
Company
Lineus Medical
Model
A
Catalog number
2855-01-0001
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.
Published
2022-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QOIIntravenous Catheter Force-Activated Separation Device.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QOIIntravenous Catheter Force-Activated Separation Device.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190043000SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical2021-05-27QOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860635000311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086063500031110860635000311

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer breakaway connectorA 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
081269269
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869184000301Orchid Safety Release ValveLinear Health Sciences, LLCQOI2022-08-31
10869184000308Orchid Safety Release ValveLinear Health Sciences, LLCQOI2022-08-31