Home GUDID M1745119C2 Serim® GUARDIAN™ Blood Leak Test Strips
Primary DI M1745119C2
Brand Serim® GUARDIAN™ Blood Leak Test Strips
Company SERIM RESEARCH CORPORATION
Model 5119C
Catalog number 5119C
Device description Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
Published 2017-02-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FJD Detector, Leak, Blood
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FJD Detector, Leak, Blood Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M1745119C2 Package HIBCC 2 Not in Commercial Distribution M1745119IN Package HIBCC 1 Not in Commercial Distribution M1745119C1 Primary HIBCC 0 M1745119C0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haemodialysis system blood leak detector An electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side.
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 25 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 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 M1745100C1 Serim® GUARDIAN™ Residual Chlorine Test Strips 5100C 5100C 2016-08-29
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M17451191 Serim® GUARDIAN™ Blood Leak Test Strips SERIM RESEARCH CORPORATION FJD 2026-01-29 M17451190 Serim® GUARDIAN™ Blood Leak Test Strips SERIM RESEARCH CORPORATION FJD 2026-01-29 00858293006175 EZ-Chek REPROCESSING PRODUCTS CORPORATION FJD 2017-03-07 00858293006397 EZ-Chek REPROCESSING PRODUCTS CORPORATION FJD 2017-03-07 M1745119C1 Serim® GUARDIAN™ Blood Leak Test Strips SERIM RESEARCH CORPORATION FJD 2017-02-12 00851575007112 SteriChek® Blood Leak Reagent Strips HACH COMPANY FJD 2016-10-28 00851575007105 SteriChek® Blood Leak Reagent Strips HACH COMPANY FJD 2016-10-28 00851575007129 SteriChek® Blood Leak Reagent Strips HACH COMPANY FJD 2016-10-28
serim.com