DEVICE: Chlorine Sentinel II (00860006352165)
Device Identifier (DI) Information
Chlorine Sentinel II
NSS-CS-II-001
In Commercial Distribution
Nelson Environmental Technologies Inc
NSS-CS-II-001
In Commercial Distribution
Nelson Environmental Technologies Inc
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.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62446 | Haemodialysis system chlorine monitor |
A mains electricity (AC-powered) component of a haemodialysis system intended to continuously measure total chlorine (total chloramines plus free chlorine) levels in water used to prepare dialysate. It performs sample collection and consists of an automated electronic assembly with a photometric colorimeter, chemical reagents which produce a colour change upon reaction with chlorine/chloramine, a stir motor, and a digital display screen to indicate chlorine concentration.
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FDA Product Code
[?]Product Code | Product Code Name |
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MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
PSX | Chlorine Meter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4932995d-ab8e-4fb4-974a-5b846935d47f
April 24, 2025
1
April 16, 2025
April 24, 2025
1
April 16, 2025
Alternative and Additional Identifiers Additional Identifiers
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined