FDA.reportPublic FDA data

Sterichek® Total Chlorine Test Kit Refill

Primary DI
00851575007068
Brand
Sterichek® Total Chlorine Test Kit Refill
Company
HACH COMPANY
Model
811902
Catalog number
811903
Device description
DPD reagent powder pillows refill, used with reagent test kit to measure low levels of total chlorine in feed water used to prepare dialysate.
Published
2016-11-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification
MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2
MSYStrip, Test, Reagent, Residuals For Dialysate, DisinfectantGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983997000STERICHEK TOTAL CHLORINE TEST KITEnvironmental Test Systems, Inc.1999-04-02MSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851575007068PrimaryGS10
00851575007013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851575007068008515750070688515750070680851575007068
00851575007013008515750070138515750070130851575007013

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis dialysate water chlorine test kitA collection of reagents and other associated materials intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. It includes test tubes, a colorimetric reagent (e.g., DPD, potassium iodide) which produces a colour change upon reaction with chlorine/chloramine, and a visual standard for colour comparison. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.15Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-970-278-4951etscustomerservice@hach.com

Regulatory Flags#

DUNS number
091381780
Device count
500
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851575007389Stericide Peroxide Reagent Strips811905B811905B2020-04-14
00851575007044SteriChek® Peroxide Reagent Strips8119058119052016-09-23
00851575007075SteriChek® Residual Peroxide Reagent Strips8119058219712016-09-23
00851575007112SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
00851575007020SteriChek® Residual Chlorine Reagent Strips8119008119002016-11-23
00851575007051SteriChek® Total Chlorine Test Kit8119028119022016-11-23
00851575007105SteriChek® Blood Leak Reagent Strips8120148120142016-10-28
00851575007143Sterichek® BiCarb pH Reagent Strips8119168119162016-10-28
00851575007150SteriChek® Peracetic Acid Reagent Strips8119068119062016-09-23
00851575007129SteriChek® Blood Leak Reagent Strips8120148121452016-10-28
00851575007273HACH974660097466002017-05-12
00851575007181HACH973010097301002017-05-12
00851575007198HACH963860096386002017-05-12
00851575007242HACH971730097173002017-05-12
00851575007297HACH963890096389002017-05-12
00851575007310HACH974730097473002017-05-12
00851575007334HACH974740097474002017-05-12
00851575007358HACH974750097475002017-05-12
00851575007365HACH975660097566002017-05-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817927020406AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020413AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
04039361261313DIASAFE®plusUSFresenius Medical Care AGFIP2026-05-01
00850001011266Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
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00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
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00860008016911Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860006352165Chlorine Sentinel IINelson Environmental Technologies IncMSY2025-04-16
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
PB0002MEDI-PORT PBII R.O. 220VBETTER WATER, LLCFIP2024-11-13
PB0003MEDI-PORT PBII R.O. 120VBETTER WATER, LLCFIP2024-11-13
PR0023"PRETREAT, 1"", 208V, CPVC, SHORT, AC"BETTER WATER, LLCFIP2024-11-13
PS0155"POST-TREAT, .03 30"", 208V"BETTER WATER, LLCFIP2024-11-13
04251285200524AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200531AquaB LITEVIVONIC GmbHFIP2024-07-25
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