Home GUDID M1745167IN2 Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips
Primary DI M1745167IN2
Brand Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips
Company SERIM RESEARCH CORPORATION
Model 5167
Catalog number 5167
Device description SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.
Published 2016-09-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M174516711 Package HIBCC 1 In Commercial Distribution M17451672 Package HIBCC 5 In Commercial Distribution M1745167IN2 Package HIBCC 1 In Commercial Distribution M17451671 Primary HIBCC 0 M17451670 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multi-parameter device tester A battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 605151018 Device count 100 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M17452120 Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips 5212 5212 2026-03-30 M17451051 Serim® GUARDIAN™ Residual Peroxide Test Strips 5105 5105 2016-09-08 M17451091 Serim® GUARDIAN™ HiSENSE™ Test Kit 5109 5109 2016-09-19 M1745119C1 Serim® GUARDIAN™ Blood Leak Test Strips 5119C 5119C 2017-02-12 M17451211 Serim® DISINTEK™ OPA Test Strips 5121 5121 2016-09-08 M1745140K1 Serim® PyloriTek® Test Kit 05140K 05140K 2016-09-19 M17451671 Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips 5167 5167 2016-09-08 M1745100A1 Serim® GUARDIAN™ Residual Chlorine Test Strips 5100A 5100A 2016-08-29 M17451052 Serim® GUARDIAN™ Residual Peroxide Test Strips 5105 5105 2016-09-08 M17451092 Serim® GUARDIAN™ HiSENSE™ Test Kit 5109 5109 2016-09-19 M1745119C2 Serim® GUARDIAN™ Blood Leak Test Strips 5119C 5119C 2017-02-12 M17451212 Serim® DISINTEK™ OPA Test Strips 5121 5121 2016-09-08 M1745136A1 Serim® DISINTEK™ GTA 1.5% Test Strips 5136A 5136A 2016-09-08 M1745116A1 Serim® GUARDIAN™ Bicarb pH II Test Strips 5116A 5116A 2016-09-19 M17451061 Serim® GUARDIAN™ Peracetic Acid Test Strips 5106 5106 2016-09-08 M17451221 Serim® PeriScreen™ Test Strips 5122 5122 2016-09-08 M17451191 Serim® GUARDIAN™ Blood Leak Test Strips Blood Leak 50's 5119 2026-01-29 M17451121 Serim® GUARDIAN™ Residual Formaldehyde Test Strips 5112 5112 2016-09-08 M17451190 Serim® GUARDIAN™ Blood Leak Test Strips Blood Leak 50's 5119 2026-01-29 M1745140K2 Serim® PyloriTek® Test Kit 05140K 05140K 2016-09-19
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