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510(k) Data Aggregation
K Number
K082511Device Name
MEDIGARD BLOOD COLLECTION DEVICE
Manufacturer
Date Cleared
2009-01-16
(140 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MEDIGARD LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical device to enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
Device Description
The Medigard Blood Collection Device Consists of two Parts 1) a blood collection tube holder and 2) an evacuated sharps collection tube Netther part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures The device is intended to be used to provide a safe and reliable method of collection of blood samples from a patient using standard evacuated blood collection tubes The device is designed to prevent accidental needle stick injury At the end of the procedure, the needle is retracted into the Medigard evacuated sharps collection tube
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