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510(k) Data Aggregation
K Number
K190539Device Name
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
Manufacturer
MonuMedical, LLC
Date Cleared
2019-10-22
(232 days)
Product Code
FMG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MonuMedical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Device Description
MonuMedical TurnSignal® Stopcocks and Manifolds are composed of a stopcock with three port three way and or three port four way body and a handle. Male connectors also include a nut for locking over the female connector or another component. A small amount of lubricant is applied between the stopcock body and handle. The manifolds contain a Halkey Roberts Swabable Port on each stopcock. MonuMedical Stopcocks will be available in a wide variety of configuration for use according to a particular situation and the clinician's preference. Duration of use should not exceed 24 hours and 7 activations of the swabable ports. The devices are provided sterile and non-sterile.
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