Myron L® Company

Primary DI
00857744006016
Brand
Myron L® Company
Company
MYRON L COMPANY
Model
D-2 Dialysate Meter™
Catalog number
D-2
Device description
A handheld, analog instrument that measures conductivity of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the conductivity of dialysate and is a Class II medical device. The D-2 features dual scales and can be used to test both acetate and bicarbonate dialysate. It is powered by a 9-volt battery. It’s FDA Product Code is FLB: Meter, Conductivity, Induction, Remote Type.
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
FLBMeter, Conductivity, Induction, Remote Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLBMeter, Conductivity, Induction, Remote TypeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857744006016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857744006016008577440060168577440060160857744006016

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Do Not Feeze

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
Serial number
true
Manufacturing 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
00857744006061Myron L® CompanySolution, NaCl, 12.5 Millimhos, QuartNACL-12.5Q2016-09-23
00857744006078Myron L® CompanySolution, NaCl, 12.5 Millimhos, GallonNACL-12.5G2016-09-23
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
00857744006009Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006023Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006030Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006047Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006054Myron L® CompanyMYRON L COMPANYFLB2016-09-23