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510(k) Data Aggregation
K Number
K120005Device Name
ACDS
Manufacturer
ISOPURE CORP.
Date Cleared
2012-03-29
(86 days)
Product Code
KPO
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ISOPURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Isopure ACDS with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients.
Device Description
The Isopure ACDS (Acidified Concentrate Distribution and Storage) is designed for storage of pre-mixed acidified concentrate in a tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists. ISOPURE ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate. The optional remote fill allows the storage tanks to be filled by the vendor from outside the building. The Isopure ACDS (Acidified Concentrate Distribution and Storage) with optional remote fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.
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K Number
K112427Device Name
BICARB MIXING AND DISTRIBUTION SYSTEM
Manufacturer
ISOPURE CORP.
Date Cleared
2012-01-26
(156 days)
Product Code
FIN
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ISOPURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.
Device Description
The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists. The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure. The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.
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K Number
K041163Device Name
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
Manufacturer
ISOPURE CORP.
Date Cleared
2004-10-07
(157 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
ISOPURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Isopure Complete Water Purification System each device is intended for use in Hemodialysis and is intended to remove organic and inorganic chemical contaminants and microbitorial contaminants from water used to dilute dialysate substances. These systems are to be use in Hospitals and/or Hemodialysis facilities.
Device Description
The Isopure Complete Water Purification System for direct feed Hemodialysis Facilities Indirect feed utilizing the MD610, MD620, MD630, MD640 Ultra Filter System. Each indirect feed model has the following optional configuration: MD610 – Single distribution pump with a series of ultra-filters based on the required flow of the facility. The MD610 has no Deionization capabilities. MD620 – Dual multi-stage distribution pumps with a series of ultra-filters based on the required flow of the facility. The MD620 has no Deionization capabilities. MD630 – Single multi-stage distribution pump with a series of ultra-filters based on the required flow of the facility. The MD630 is equipped to process a single bank of medical grade Deionization exchange tanks. MD640 – Dual multi-stage distribution pumps with automatic pump alternation with a series of ultra-filters based on the required flow of the facility. The MD640 is equipped to process dual banks of medical grade Deionization exchange tanks. The MD640 is capable of operating continuously by automatically alternating between the two banks of exchange tanks.
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K Number
K993200Device Name
MD 420/440/460/470/480/490
Manufacturer
ISOPURE CORP.
Date Cleared
2000-01-24
(122 days)
Product Code
FIP
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
ISOPURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MD 420-490 series reverse osmosis system is intended to purify water for hemodialysis when used as a component of a complete water purification system.
Device Description
The MD 420-490 Series is a Reverse Osmosis Machine used in purifying water. The MD 420-490 series features an advanced electronic package including a PLC with software and validation procedures and a Touch-screen. The new advanced system has the capability to monitor both the pre-treatment and posttreatment of the water room. The data can be printed for a daily log or modem to a remote location. The machine is now simpler, quieter, and easier to maintain, run, and service compared to the MD 400 A-F. The PLC can monitor all aspects of the water room including the RO, pre-treatment, storage tank, line and loop pressures, temperatures, and flows. The system will display membrane % rejection and % recovery. All of this data is sent back to the RO where it is displayed. The data also has the capability to be modemed to a remote location. The hydraulic design of the machine remains unchanged for the original 510(k) application, however, we now use SCH 80 PVC pipe and 316L Stainless Steel piping in place of the tubing originally used of the HD- MD series.
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