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510(k) Data Aggregation
K Number
K050805Device Name
30 ML OR 60 ML PEDI-SYRINGE FILTER
Manufacturer
BLOOD PRODUCTS SPECIALTIES LLC
Date Cleared
2005-06-20
(82 days)
Product Code
BRZ, FMF
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
BLOOD PRODUCTS SPECIALTIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.
Device Description
Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp.
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