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510(k) Data Aggregation
K Number
K200932Device Name
Blood Collection Needles
Manufacturer
Date Cleared
2021-12-14
(616 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Vacutest Kima Srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
Device Description
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
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