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510(k) Data Aggregation
K Number
K041496Device Name
PENTATRASFU BLOOD TRANSFUSION SETS
Manufacturer
PENTAFERTE S.P.A
Date Cleared
2005-06-30
(391 days)
Product Code
BRZ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PENTAFERTE S.P.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To Administer Blood to the patient's vascular system.
To administer Blood and Blood Derivatives into a patient's vascular system
Device Description
The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.
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K Number
K041495Device Name
PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
Manufacturer
PENTAFERTE S.P.A
Date Cleared
2005-04-15
(315 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PENTAFERTE S.P.A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To Administer IV Fluids/medications to the patient's vascular system.
To administer IV Fluids into a patient's vascular system
Device Description
The PENTADEFLU IV Administration Sets are Single Use, Sterile, Non-Pyrogenic devices used to administer IV fluids/medications to a patient's vascular system via gravity control.
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