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510(k) Data Aggregation
K Number
K023509Device Name
DBB-05 HEMODIALYSIS DELIVERY SYSTEM
Manufacturer
DAVITA CLINICAL RESEARCH (TRRI)
Date Cleared
2003-10-30
(377 days)
Product Code
KDI
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
DAVITA CLINICAL RESEARCH (TRRI)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.
Device Description
The subject device is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyser through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyser is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyser. Heparinization of the external circulating blood can be done with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser. The subject device uses both acetate dialysis and bicarbonate dialysis. Using the various functions the device, the conductivity and UF profile can be programmed. In addition, the subject device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.
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