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510(k) Data Aggregation

    K Number
    K201765
    Device Name
    SmartHDM-510 System
    Manufacturer
    Mesa Laboratories, Inc.
    Date Cleared
    2020-09-02

    (65 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mesa Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pH and flow of the dialysate solution used with hemodialysis delivering systems. The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications. The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
    Device Description
    The SmartHDM-510 System is designed for the installation and maintenance of hemodialysis delivering systems. The system consists of different sensors and sensor-modules to measure conductivity, temperature, pressure, pH and flow and an Android operating system based display module with SmartHDM-510 App. The SmartHDM-510 system consists of: - HDU-Sensors for Conductivity/Temperature, Pressure, pH and flow - HDM-Sensor Modules for Conductivity/Temperature, Pressure, - 90XL-Sensors for Conductivity/Temperature, Pressure and pH - Android-based Display Module with SmartHDM-510 App.
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    K Number
    K191496
    Device Name
    TDS Standard Solution
    Manufacturer
    Mesa Laboratories, Inc.
    Date Cleared
    2019-08-05

    (61 days)

    Product Code
    FKH
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mesa Laboratories, Inc.

    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
    K150657
    Device Name
    Phoenix XL Dialysate Meter
    Manufacturer
    Mesa Laboratories, Inc.
    Date Cleared
    2015-09-21

    (192 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mesa Laboratories, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.
    Device Description
    This device is a hand-held battery powered, multi-test meter designed for use by hemodialysis professionals to measure the conductivity, temperature and pH of Dialysate solutions associated with the dialysis treatment. The unit houses the conductivity cell, electronic circuitry and digital display. A syringe attaches to the unit with luer connectors. When pulled, the syringe creates a vacuum and draws solution through the conductivity cell for measurement. The conductivity cell contains the conductivity electrodes, a thermistor, and a pH electrode. A 3.6 volt battery provides power.
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    K Number
    K140589
    Device Name
    STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2014-12-03

    (271 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STERRAD® CYCLESURE® 24 PLUS Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilizer Systems used in Healthcare facilities: - · STERRAD® 50 - · STERRAD® 100S - · STERRAD® 200 - · STERRAD® NX Standard Cycle - · STERRAD® NX Advanced Cycle - · STERRAD® 100NX STANDARD Cycle - · STERRAD® 100NX FLEX Cycle - · STERRAD® 100NX DUO Cycle - · STERRAD® 100NX EXPRESS Cycle
    Device Description
    Not Found
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    K Number
    K130100
    Device Name
    COMINED STANDARD SOLUTION
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2013-04-18

    (93 days)

    Product Code
    FKH
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    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
    K122362
    Device Name
    SMART-WELL INCUBATOR
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2013-03-26

    (232 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. Smart-Read EZTest is a Self-contained Biological Indicator (SCBI) intended for use in determining the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles: Gravity 121°C 30 minutes, Gravity 132°C 10 minutes, Flash Gravity 132°C 3 minutes* (*Unwrapped nonporous devices only.), Pre-Vac 132°C 4 minutes, Pre-Vac 135°C 3 minutes. Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested. The printer can also display information that is normally entered into a log book. The printer can also be configured to display Bl exposure information that includes Bl Lot number, Sterilizer number, User identification and Cycle ID. If no selection is made for these options during the BI Wizard set up, the printed report will print a "?" mark indicating no selection was made. The printed record will always indicate incubation cavity being reported. Bl results (status), incubation start date and time when the SCB! was placed into the incubation cavity and the total time of incubation. The result options are 1) NEGATIVE (purple)-incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow)—time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING-when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers.
    Device Description
    The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). When an activated Smart-Read EZTest Steam SCBI is placed into one of the incubation cavilies the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest Steam SCBI unit for incubation. Each incubation cavily also has an electronic monitoring system that detects if the Bl is either purple or yellow. The Smart-Well Model 1710 EZTest Incubator can also be supplied with a printer which documents each individual Smart-Read EZTest Steam SCBI tested.
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    K Number
    K112018
    Device Name
    SMART READ EZTEST STEAM
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2012-01-30

    (200 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles: | Cycle Type | Cycle Temp | Cycle Exposure Time | |---------------|------------|---------------------| | Gravity | 121°C | 30 Minutes | | Gravity | 132°C | 10 Minutes | | Flash Gravity | 132°C | 3 Minutes* | | Pre-Vac | 132°C | 4 Minutes | | Pre-Vac | 135°C | 3 Minutes | *Unwrapped nonporous devices only Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.
    Device Description
    The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 incculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. Smart Read EZTest - Steam is intended for use in monitoring the efficacy of steam sterilization processes with minimum exposure times of 20 minutes at 121 ℃ gravity displacement, 10 minutes at 132°C gravity displacement and 3 minutes at 132°C flash gravity displacement cycles.
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    K Number
    K050812
    Device Name
    90XL INSTRUMENTATION SYSTEM
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2005-05-05

    (35 days)

    Product Code
    FIZ
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and documentation for effective hemodialysis systems.
    Device Description
    Not Found
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    K Number
    K033330
    Device Name
    CONDUCTIVITY/TDS CALIBRATOR SOLUTION
    Manufacturer
    MESA LABORATORIES, INC.
    Date Cleared
    2004-02-27

    (134 days)

    Product Code
    FKH
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESA LABORATORIES, INC.

    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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