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510(k) Data Aggregation
K Number
K023064Device Name
HEMOCLEAN
Manufacturer
KRD CO., LTD
Date Cleared
2004-04-06
(568 days)
Product Code
NII
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
KRD CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition:
| Hemodialysis Machine | Dilution rate | Contact time |
|----------------------|---------------|--------------|
| COBE CentrySystem 3 | 1:9 | 10 minutes. |
| Nikkiso DBB 22B | 1:34 | 29 minutes. |
| Fresenius 2008K. | 1:34 | 15 minutes. |
| Gambro Phoenix | 1:25 | 15 minutes. |
Device Description
HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%; inert ingredients are 93%. The product is a clear colorless liquid, high acid, and completely soluble in water. HEMOCLEAN® finally breaks down to carbon dioxide, water, and oxygen. The product is used full strength with automated dilution by the hemodialysis machine for the intended use. It is packaged in five liters polyethylene containers with a vent filter on the cap and is shipped in two 5-liter containers per box. The shelf life of the concentrate is one year when properly stored.
HEMOCLEAN® is indicated for the disinfection of hemodialysis machines. To use HEMOCLEAN® in automated hemodialysis machines, the user should follow the manufacture's recommendations for dilution of peracetic acid-based disinfectants. AAMI-quality water for hemodialysis must be used for diluting HEMOCLEAN® in the hemodialysis machine.
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