DEVICE: Basic Chlorine Sentinel (00860006352103)

Device Identifier (DI) Information

Basic Chlorine Sentinel
NSS-BCS-001
In Commercial Distribution

Nelson Environmental Technologies Inc
00860006352103
GS1

1
835316464 *Terms of Use
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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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
PSX Chlorine Meter
MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
FIP Subsystem, Water Purification
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
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Device Record Status

13131fdc-e803-44d2-acab-35465555da12
July 14, 2022
1
July 06, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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