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

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Primary Device ID10860635000311
NIH Device Record Key6d68c13a-9967-417b-b8bf-4d1d8cb2b08a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeBreak - Vascular
Version Model NumberA
Catalog Number2855-01-0001
Company DUNS081269269
Company NameLineus Medical
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110860635000311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QOIIntravenous Catheter Force-Activated Separation Device.

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-28
Device Publish Date2022-06-20

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