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510(k) Data Aggregation
K Number
K072542Device Name
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
Manufacturer
MEDEGEN MEDICAL MANUFACTURING SYSTEM
Date Cleared
2007-09-25
(15 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDEGEN MEDICAL MANUFACTURING SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxPlus is a sterile single patient use Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxPlus connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Device Description
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K Number
K051939Device Name
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
Manufacturer
MEDEGEN MEDICAL MANUFACTURING SYSTEM
Date Cleared
2005-08-01
(14 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDEGEN MEDICAL MANUFACTURING SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.
Device Description
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