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510(k) Data Aggregation
K Number
K191496Device Name
TDS Standard Solution
Manufacturer
Mesa Laboratories, Inc.
Date Cleared
2019-08-05
(61 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Product Code :
FKH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.
Device Description
The device consists of salts (Sodium Chloride, Sodium Bicarbonate and Sodium Sulfate) dissolved in de-ionized water. The solution is packaged into sealed polyethylene bottles.
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K Number
K130100Device Name
COMINED STANDARD SOLUTION
Manufacturer
MESA LABORATORIES, INC.
Date Cleared
2013-04-18
(93 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Product Code :
FKH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.
Device Description
The device consists of salts (Sodium Chloride, Sodium Phosphate Dibasic, and Potassium Phosphate Monobasic) dissolved in de-ionized water. The proportion of total salt determines the solution's conductivity. The proportions of Sodium Phosphate Dibasic and Potassium Phosphate Monobasic determine the solution's pH. The solution is packaged into sealed polyethylene bottles. The performance specifications of the device are a pH value of pH 7.0 ± 0.03 pH units and a conductivity value of 14.00 mS/cm ± 0.03 mS/cm. The solution should maintain these values for 18 months stored in a sealed bottle. The solution should also maintain these values for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.
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K Number
K041636Device Name
H&S-CONDUCTIVITY STANDARD SOLUTION
Manufacturer
H & S TECHNICAL SERVICES
Date Cleared
2004-07-02
(15 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Product Code :
FKH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include the odilibrator of conduction to verify or calibrate conductivity or calibrate conductivity functions of dialysis related equipment.
These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.
Device Description
H&S - Conductivity Standard Solution is salt-based liquid produced by dissolving reagent grade salt in treated water and equilibrated to atmospheric CO2. The salt concentration determines the conductivity value. The solution is packaged in various size polyethylene bottles and sealed with a taper indicator seal and cap. The product label is added, and the device is placed in a clear plastic bag The product label contains instructions for use, warnings, and other safety information. H&S - Conductivity Standard Solution is available in of a range sizes, values and accuracies.
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K Number
K033330Device Name
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
Manufacturer
MESA LABORATORIES, INC.
Date Cleared
2004-02-27
(134 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Product Code :
FKH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells and instruments. The Conductivity/TDS Calibrator Solutions may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the equipment, and do not come into contact with the patient.
Device Description
The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles.
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K Number
K032075Device Name
CONDUCTIVITY STANDARD SOLUTION-METERCARE
Manufacturer
IBP INSTRUMENTS GMBH
Date Cleared
2003-09-17
(72 days)
Product Code
FKH
Regulation Number
876.5820Why did this record match?
Product Code :
FKH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems. MeterCare is an Over-the-Counter product and needs no prescription. The product is for In Vitro use only.
Device Description
The "Conductivity Standard Solution – MeterCare" is a range of high accuracy conductivity standard solutions to calibrate conductivity meters used in dialysis to test the conductivity of dialysate of dialysis machines and water used in hemodialysis applications.
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