Device Description : Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chl Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of c Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of pero Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (c The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate conce Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate conce Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during thehemodialysis procedure.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No
Device Description : Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.
Device Class :
Duns Number: 605151018
Premarket Exempt : No
Prescription Use : No