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510(k) Data Aggregation
K Number
K031279Device Name
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
Manufacturer
TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD.
Date Cleared
2003-05-30
(38 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
The Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, female connector with a multi-sample luer adapter attached for blood collection.
A hinged shield cover is attached to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
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