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Chlorine Sentinel II

FDA UDI

Class II (US FDA UDI)

by Nelson Environmental Technologies Inc

Identity

Trade Name
Chlorine Sentinel II FDA UDI
Generic Name
Haemodialysis system chlorine monitor FDA UDI
Device Name
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. FDA UDI
Model / Reference
NSS-CS-II-001 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860006352165 FDA UDI
FDA Product Code
MSY FDA UDI
PSX FDA UDI
GMDN Term
Haemodialysis system chlorine monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Haemodialysis system chlorine monitor

Chlorine Sentinel II by Nelson Environmental Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system chlorine monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nelson Environmental Technologies Inc

Sources (1)

  • FDA UDI 4932995d-ab8e-4fb4-974a-5b846935d47f 33 fields · synced Jun 8, 2026