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510(k) Data Aggregation
K Number
K233979Device Name
VACUETTE® QUICKSHIELD Complete (Plus)
Manufacturer
Greiner Bio-One North America Inc
Date Cleared
2024-07-19
(214 days)
Product Code
JKA, FMI
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Greiner Bio-One North America Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
Device Description
The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
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