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510(k) Data Aggregation
K Number
K150966Device Name
HMB32
Manufacturer
HAEMOPHARM BIOFLUIDS SRL
Date Cleared
2015-12-04
(235 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
HAEMOPHARM BIOFLUIDS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.
Device Description
The HBiofluids HMB32 is a bicarbonate based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is broken, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment.
The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500+4500 ml and 500+1500 ml.
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