HACH COMPANY

Address:100 DAYTON AVE.,AMES,IA,50010,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (MSY) (4) Dialyzer Reprocessing System (LIF) (3) Subsystem, Water Purification (FIP) (3) Detector, Leak, Blood (FJD) (2) Chlorine Meter (PSX) (1) Strip, Dialysate Ph Indicator (MNV) (1)

Premarket Exempt

Clear

SteriChek® Residual Chlorine Reagent Strips - 00851575007020 Catalog Number : 811900

Device Description : Reagent test strip for measuring the concentration of residual chlorine (i.e. fr Reagent test strip for measuring the concentration of residual chlorine (i.e. from chlorine bleach) in rinse water following disinfection of hemodialysis equipment.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : MSY

Prescription Use : No

Device Count : 500

SteriChek® Peroxide Reagent Strips - 00851575007044 Catalog Number : 811905

Device Description : Reagent test strips used to measure the concentration of residual peroxide in ri Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 500

SteriChek® Total Chlorine Test Kit - 00851575007051 Catalog Number : 811902

Device Description : Reagent test kit used to measure low levels of total chlorine in feed water used Reagent test kit used to measure low levels of total chlorine in feed water used to prepare dialysate.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, MSY

Prescription Use : No

Device Count : 100

Sterichek® Total Chlorine Test Kit Refill - 00851575007068 Catalog Number : 811903

Device Description : DPD reagent powder pillows refill, used with reagent test kit to measure low lev DPD reagent powder pillows refill, used with reagent test kit to measure low levels of total chlorine in feed water used to prepare dialysate.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : FIP, MSY

Prescription Use : No

Device Count : 500

SteriChek® Residual Peroxide Reagent Strips - 00851575007075 Catalog Number : 821971

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1200

SteriChek® Blood Leak Reagent Strips - 00851575007105 Catalog Number : 812014

Device Description : Reagent test strips used to test for the presence of blood in dialysate fluid du Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : FJD

Prescription Use : No

Device Count : 60

SteriChek® Blood Leak Reagent Strips - 00851575007112 Catalog Number : 812145

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : FJD

Prescription Use : No

Device Count : 10

Sterichek® BiCarb pH Reagent Strips - 00851575007143 Catalog Number : 811916

Device Description : Reagent test strip used to measure hydrogen ion concentration (pH) in bicarbonate buffer

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : MNV

Prescription Use : No

Device Count : 500

SteriChek® Peracetic Acid Reagent Strips - 00851575007150 Catalog Number : 811906

Device Description : Reagent test strip for measuring the concentration of peracetic acid in dialyzer Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.

Device Class :

Duns Number: 091381780

Premarket Exempt : No

Product Code : MSY, LIF

Prescription Use : No

Device Count : 600

HACH - 00851575007181 Catalog Number : 9730100

Device Description : REMOTE INDICATOR ASSY, CM130

Device Class : 2

Duns Number: 091381780

Premarket Exempt : No

Product Code : PSX, FIP

Prescription Use : Yes

Device Count : 1

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