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510(k) Data Aggregation
K Number
K092905Device Name
AUTOSTART BURETTE
Manufacturer
Date Cleared
2010-03-04
(164 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ANALYTICA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Administration of fluids from a container to a patient's vascular system through a cannula inserted into a vein.
Device Description
The AutoStart Burette is an in-line burette used for intravenous administration of fluids (either gravitational or via an infusion pump) from a container to a patient's vascular system through a cannula inserted into a vein. This is a sterile, single-use device. The device is fitted with a float system which that allows the primary infusion to restart following addition to and dispensation of medication from the burette. There is no need to manually restart the infusion as is the case with conventional in-line burettes.
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