Myron L® Company

Primary DI
00857744006030
Brand
Myron L® Company
Company
MYRON L COMPANY
Model
D-4 Digital Dialysate Meter™, bluDock Capable
Catalog number
D-4BD
Device description
A handheld, multi-function digital device that measures conductivity and temperature of water and dialysate fluids associated with hemodialysis delivery systems. It is used for monitoring the temperature and conductivity of dialysate and a Class II medical device. It can test both acetate and bicarbonate dialysate quality. Internal sensors require the user to place the sample in the instrument, preventing contamination of dialysate by the measurement device. The BD version is equipped with a bluDock wireless communication module. 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
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100237000DIALYSATE METER, MODEL D-6Myron L Company2010-04-23FLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857744006030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857744006030008577440060308577440060300857744006030

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
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature0 Degrees Celsius55 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
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
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
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
00857744006016Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006023Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006047Myron L® CompanyMYRON L COMPANYFLB2016-09-23
00857744006054Myron L® CompanyMYRON L COMPANYFLB2016-09-23