FDA.reportPublic FDA data

Myron L® Company

Primary DI
00857744006078
Brand
Myron L® Company
Company
MYRON L COMPANY
Model
Solution, NaCl, 12.5 Millimhos, Gallon
Catalog number
NACL-12.5G
Device description
NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857744006078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857744006078008577440060788577440060780857744006078

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Gallon

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-760-438-2021techquestions@myronl.com

Regulatory Flags#

DUNS number
064468689
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857744006023Myron L® CompanyD-4 Digital Dialysate Meter™D-42016-09-23
00857744006030Myron L® CompanyD-4 Digital Dialysate Meter™, bluDock CapableD-4BD2016-09-23
00857744006047Myron L® CompanyD-6 Digital Dialysate Meter™D-62016-09-23
00857744006054Myron L® CompanyD-6 Dialysate Meter™, bluDock CapableD-6BD2016-09-23
00857744006009Myron L® CompanyD-1 Dialysate Meter™D-12016-09-23
00857744006016Myron L® CompanyD-2 Dialysate Meter™D-22016-09-23
00857744006061Myron L® CompanySolution, NaCl, 12.5 Millimhos, QuartNACL-12.5Q2016-09-23
00857744006085Myron L® CompanySolution, NaCl, 13.4 Millimhos, QuartNACL-13.4Q2016-09-23
00857744006092Myron L® CompanySolution, NaCl, 13.4 Millimhos, GallonNACL-13.4G2016-09-23
00857744006108Myron L® CompanySolution, NaCl, 14.0 Millimhos, 2 OuncesNACL-14.02OZ2016-09-23
00857744006115Myron L® CompanySolution, NaCl, 14.0 Millimhos, QuartNACL-14.0Q2016-09-23
00857744006122Myron L® CompanySolution, NaCl, 14.0 Millimhos, GallonNACL-14.0G2016-09-23
00857744006221Myron L® CompanyPortaKit for D-6 Digital Dialysate MeterPKD2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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