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510(k) Data Aggregation
K Number
K172957Device Name
Kawasumi Laboratories Blood Drawing Kit (BDK) System
Manufacturer
Kawasumi Laboratories, Inc.
Date Cleared
2018-09-28
(367 days)
Product Code
KSB, FMI, LHI
Regulation Number
864.9875Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
Device Description
The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion. The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling. The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a sterile, single-use device that consists of the following components: Needle Protector, Cannula, Hub, Wing, Antineedle Stick Protector "K-Shield", Tubing, Needleless Access Connector (NAC) Y-Site, Clamp, Blood Bag Unit Reservoir.
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