Search Results
Found 1 results
510(k) Data Aggregation
K Number
K162233Device Name
Kurin Blood Culture Collection Set
Manufacturer
Date Cleared
2016-12-23
(137 days)
Product Code
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Pathway LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.
Device Description
The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.
Ask a Question
Ask a specific question about this device
Page 1 of 1