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LINEUS MEDICAL

Matched from indexed company URL: Lineus Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30195116593019511659LINEUS MEDICAL1N2026-01-01179 North Church Avenue Suite 202 Fayetteville AR US 72701

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2937891324879489K231957SafeBreak® VascularQOI2023-09-29
2937891883660985K223486SafeBreak® VascularQOI2023-05-19
2937891886415613K222791SafeBreak VascularQOI2022-10-16
2937891167268011DEN190043SafeBreak VascularQOI2021-05-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QOI42023-09-29

PMN#

GUDID#

SafeBreak - Vascular - 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

2022-06-20