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

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis conductivity standard solutionA salt solution, typically salt dissolved in deionized/purified water, used to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. The solution is typically available in sealed plastic bottles and in a range of values and accuracies. It may be available over-the-counter. This is a single-use device.

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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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
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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