FDA.reportPublic FDA data

Nipro Techincal Solutions, Inc. Conductivity Standard Solutions

Primary DI
00850016976246
Brand
Nipro Techincal Solutions, Inc. Conductivity Standard Solutions
Company
Nipro Technical Solutions, Inc.
Model
10026
Device description
TDS Solution 442, 229µS (150ppm), 32oz. (946mL) Boston Round
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K041636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041636000H&S-CONDUCTIVITY STANDARD SOLUTIONH & S Technical Services2004-07-02FKH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016976246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016976246008500169762468500169762460850016976246

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-923-2486sales@niprotechnical.com

Regulatory Flags#

DUNS number
139015999
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016976000Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100012026-05-15
00850016976017Nipro Techincal Solutions, Inc. Conductivity Standard Solutions10001c2026-05-15
00850016976024Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100022026-05-15
00850016976086Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100102026-05-15
00850016976093Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100112026-05-15
00850016976154Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100172026-05-15
00850016976161Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100182026-05-15
00850016976185Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100202026-05-15
00850016976192Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100212026-05-15
00850016976208Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100222026-05-15
00850016976215Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100232026-05-15
00850016976222Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100242026-05-15
00850016976239Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100252026-05-15
00850016976253Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100272026-05-15
00850016976260Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100282026-05-15
00850016976277Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100292026-05-15
00850016976284Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100302026-05-15
00850016976291Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100312026-05-15
00850016976314Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100322026-05-15
00850016976321Nipro Techincal Solutions, Inc. Conductivity Standard Solutions100372026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016976000Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976017Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976024Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
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
00850016976208Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976215Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976222Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976239Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
00850016976253Nipro Techincal Solutions, Inc. Conductivity Standard SolutionsNipro Technical Solutions, Inc.FKH2026-05-15
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
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M985020075TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04
M985020076TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04
M985020077TDS Standard SolutionMESA LABORATORIES, INC.FKH2020-05-04