FDA.reportPublic FDA data

HACH

Primary DI
00851575007358
Brand
HACH
Company
HACH COMPANY
Model
9747500
Catalog number
9747500
Device description
STIR MOTOR REPLACEMENT MODULE KIT
Published
2017-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification
PSXChlorine Meter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2
PSXChlorine MeterGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162471000Hach CM130 Chlorine Monitoring SystemHach Company2017-03-30PSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851575007358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851575007358008515750073588515750073580851575007358

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system chlorine monitorA mains electricity (AC-powered) component of a haemodialysis system intended to continuously measure total chlorine (total chloramines plus free chlorine) levels in water used to prepare dialysate. It performs sample collection and consists of an automated electronic assembly with a photometric colorimeter, chemical reagents which produce a colour change upon reaction with chlorine/chloramine, a stir motor, and a digital display screen to indicate chlorine concentration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-227-4224orders@hach.com

Regulatory Flags#

DUNS number
091381780
Device count
1
Kit
true
Serial number
true
Manufacturing 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
00851575007068Sterichek® Total Chlorine Test Kit Refill8119028119032016-11-23
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
00851575007365HACH975660097566002017-05-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817927020376AmeriWater Chemical Feed SystemAMERIWATER, LLCFIP2026-05-08
00817927020383AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
00817927020390AmeriWater® Alarm PanelAMERIWATER, LLCFIP2026-05-08
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
00850001011341Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00850001011358Tablo(R) Hemodialysis SystemOutset Medical, Inc.FIP2025-09-21
00860008016942Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFIP2025-07-16
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 IncPSX2025-04-16
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
04251285200548AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200555AquaB LITEVIVONIC GmbHFIP2024-07-25
04251285200562AquaB LITEVIVONIC GmbHFIP2024-07-25