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510(k) Data Aggregation
K Number
K030652Device Name
MEDRO SPD
Manufacturer
U.S. FILTER/IONPURE, INC.
Date Cleared
2003-09-03
(187 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
U.S. FILTER/IONPURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USFilter MedRO - SPD is a single/acute care patient reverse osmosis unit intended to supply water that is used for hemodialysis treatments. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001) and the CSA Water Treatment Equipment and Water Quality Requirements for Hemodialysis (CSA-Z364.2.2-03) when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
Device Description
MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.
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K Number
K013677Device Name
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
Manufacturer
U.S. FILTER/IONPURE, INC.
Date Cleared
2002-03-08
(121 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
U.S. FILTER/IONPURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USFilter/lonpure Med-RO™ Reverse Osmosis System is intended to supply water for use in the preparation of dialysate for hemodialysis patients and for other hemodialysis-related procedures such as cleaning, rinsing of equipment, and reprocessing of dialyzers. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications RD 62:2001[RD-5: 1992 if Treatment Equipment for Temodiarysle Applications RD & LES T.(RE ST 1000 in conjunction with other components of a water treatment system as necessary with compatible input and output water requirements.
Device Description
The Med-RO™ Reverse Osmosis System is a machine used to purify water.
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K Number
K980182Device Name
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Manufacturer
U.S. FILTER/IONPURE, INC.
Date Cleared
1998-11-16
(300 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
U.S. FILTER/IONPURE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USFitter water punfication systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from the subcent can be dilute dialysis concentrate to form water used to cince broyous began for other Gialysate, and rinse and disinfection.
Device Description
Water Purification System
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