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510(k) Data Aggregation
K Number
K043328Device Name
MICROFLO-SAFE SCALP VEIN SET
Manufacturer
Date Cleared
2005-04-15
(134 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
DKS LOVERSAN INDUSTRIA BIOMEDICA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor 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 MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. 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.
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