FDA UDI In Commercial Distribution 🇺🇸 United States

Basic Chlorine Sentinel

DI: 00860006352103 · Model: NSS-BCS-001 · Nelson Environmental Technologies Inc
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Basic Chlorine Sentinel
Primary DI
00860006352103
Version / Model
NSS-BCS-001
Company Name
Nelson Environmental Technologies Inc
Labeler DUNS
835316464
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-06
Public Version
1
Public Version Date
2022-07-14
Public Version Status
New
Public Device Record Key
13131fdc-e803-44d2-acab-35465555da12

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
62446 Haemodialysis system chlorine monitor

Identifiers

Type ID
Primary 00860006352103