FDA.reportPublic FDA data

TDS Standard Solution

Primary DI
M985020078
Brand
TDS Standard Solution
Company
MESA LABORATORIES, INC.
Model
02.0078
Catalog number
02.0078
Device description
Total Dissolved Solids Solution 1500ppm 2060uS/cm 1Pt
Published
2020-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FKHSolution-Test Standard-Conductivity, Dialysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKHSolution-Test Standard-Conductivity, DialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191496000TDS Standard SolutionMesa Laboratories, Inc.2019-08-05FKH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M985020584PackageHIBCC12In Commercial Distribution
M985020078PrimaryHIBCC0

Regulatory Flags#

DUNS number
102530326
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M98551000T1Dual Spore Strips - Test10e5/10e65-1000T2017-10-20
M985CIDHI1Mesa Labs Dry Heat Indicator LabelsCI-DHICI-DHI2016-11-30
M985CISSIX1ProChem SSE EmulatorCI-SSIXCI-SSIX2016-11-30
M985CIBDTLF0Bowie Dick Type TestProChemCI-BDTLF2016-10-24
M9850141001Spore Strip10e41-41002025-01-15
M9850161001Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341001Spore Strip10e43-41002025-01-15
M9850351001Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361001Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C1Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T1Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985055100T1Dual Spore Strip - Test10e5, 10e65-5100T2025-01-15
M9850141000Spore Strip10e41-41002025-01-15
M9850161000Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341000Spore Strip10e43-41002025-01-15
M9850351000Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361000Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C0Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T0Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsHF-Y52HF-Y522024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016976086Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976093Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976154Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976161Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976185Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976192Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
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00850016976215Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
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00850016976239Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
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00850016976260Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976277Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976284Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976291Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976314Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976321Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976352Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976369Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976376Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976383Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00860007777110Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
M985020073TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04
M985020074TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04
M985020075TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04
M985020076TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04