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510(k) Data Aggregation

    K Number
    K243898
    Device Name
    Chlorine Sentinel II
    Manufacturer
    Nelson Environmental Technologies, Inc.
    Date Cleared
    2025-04-11

    (113 days)

    Product Code
    MSY, PSX
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chlorine Sentinel II is intended for use by hemodialysis professionals as a secondary chlorine device to provide continuous monitoring of Combined Chlorine. It is not intended to replace the primary method of monitoring chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system does not come into direct contact with feed water used to prepare dialysate.
    Device Description
    Chlorine Sentinel II is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. It detects dissolved combined chlorine in concentrations at or above 10 PPB by primary detection technology. It self-monitors for maintenance-required conditions and loss of electrical power. The Chlorine Sentinel II is self-testing. It uses chlorinated city water to automatically test the chlorine detecting functionality of the device once a day and records if the test passed, failed to detect chlorine, or didn't rinse out after detecting chlorine. The device is designed to use as little water as possible. The sampling water is only used for the length of time that it takes for the chlorine test to be completed. The customer determines how frequently the test needs to be taken from every 5 minutes to every 20 minutes. The user also sets the start time and end time for each day of the week. The Chlorine Sentinel II has two combined chlorine concentration set points. The user can set a warning set-point at a value of 0.01 PPM to 0.09 PPM. Once the chlorine concentration exceeds this value, the device will alarm at 2-HZ to warn the user of chlorine present at that set-point. The second set-point is factory set at 0.10 PPM. A chlorine concentration equal to or above the 0.10 PPM set-point will activate the buzzers and the red chlorine alarm indicators at 5 HZ for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The alarms can be by-passed. When by-passed the pulsing lights will turn solid and the buzzer will double click over 15 minutes. The front cover of the device has two screens. The screen of the chlorine monitor indicates the presence of combined chlorine when the value is not 0.000. The touch screen is used to enter user data and show the statuses of the device.
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    K Number
    K222167
    Device Name
    E-Z Chek Chlorine Residual Test Strips (K100-0101B)
    Manufacturer
    Reprocessing Products Corporation (RPC)
    Date Cleared
    2022-10-18

    (89 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    E-Z Chek® Residual Chlorine Test Strips (K100-0101B) provide accurate and convenient means of measuring the concentration of free chlorine remaining in water when rinsing out equipment following disinfection. A rapid screening qualitative method will detect levels above 0.5ppm (mg/L) while the 30 second semi-quantitative method allows interpolation of concentration between 0ppm and 5ppm. The qualitative method can be used to determine that chlorine has been adequately rinsed from the equipment. The semi-quantitative method may be useful when corrective measures are undertaken on equipment retaining higher levels of chlorine for extended periods and for testing any containers disinfected with free chlorine (bleach).
    Device Description
    Reprocessing Products Corporation (RPC) E-Z Chek® Residual Chlorine Test Strips (K100-0101B) is semi-quantitative or qualitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with free chlorine and combined chlorine (monochloramines). The pad is attached to a plastic strip for handling.
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    K Number
    K193169
    Device Name
    Nelson Sentinel Series Basic Chlorine Sentinel
    Manufacturer
    Nelson Environmental Technologies, Inc.
    Date Cleared
    2020-10-29

    (349 days)

    Product Code
    MSY, FIP, PSX
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.
    Device Description
    The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop. The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area. A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller. A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.
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    K Number
    K132344
    Device Name
    E-Z CHECK OZONE TEST STRIPS
    Manufacturer
    REPROCESSING PRODUCTS CORPORATION (RPC)
    Date Cleared
    2014-02-25

    (211 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Products Corporation (RPC) E-Z Chek® Ozone Test Strips (K100-0111) are designed to indicate the presence of ozone in water used in hemodialysis. The test strips will measure equal to 0.0, 0.05, 0.1, 0.2, 0.3, 0.4, and >0.5 mg/L.
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals, which change color upon contact with Ozone. The pad is attached to a plastic strip for handling.
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    K Number
    K090338
    Device Name
    ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
    Manufacturer
    REPROCESSING PRODUCTS CORP.
    Date Cleared
    2009-05-08

    (87 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
    Device Description
    Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling. The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.
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    K Number
    K080712
    Device Name
    SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-05-06

    (54 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
    Device Description
    The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
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    K Number
    K002011
    Device Name
    GLUTARTEST 1 REAGENT STRIP
    Manufacturer
    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
    Date Cleared
    2001-01-22

    (203 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001194
    Device Name
    STERICHEK TOTAL CHLORINE REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2000-07-11

    (90 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994226
    Device Name
    STERICHEK TOTAL CHLORINE REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2000-03-22

    (98 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the concentration of total chlorine present in the sample.
    Device Description
    The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the amount of total chlorine present in the sample.
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    K Number
    K983997
    Device Name
    STERICHEK TOTAL CHLORINE TEST KIT
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1999-04-02

    (143 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Product Code :

    MSY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.
    Device Description
    The device consists of utilizing a fixed sample size of powdered reagent with a predetermined water sample volume in a test tube to effect a color reaction in the water sample. The color of the sample is then visually compared to a colormetric comparator to determine the total chlorine level in the sample. The device utilizes a recognized standard method of analysis for determining levels of total chlorine in water according to the Association for the Advancement of Medical Instrumentation (1993 Association for the Advancement of Medical Instrumentation-ANSI/AAMI;RD5-1992).
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