Myron L® Company PKD

GUDID 00857744006221

An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case. Contains 1 (one) each 2 oz bottle of 14.0 millimohs, NaCl Standard Solution (P/N NACL-14.02OZ; UDI# 00857744006108). This is the only listed component included this item. The D-6 Dialysate Meter™ is packaged separately. 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.

MYRON L COMPANY

Haemodialysis conductivity standard solution
Primary Device ID00857744006221
NIH Device Record Key7222b365-5068-4dcf-b850-a23778946779
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyron L® Company
Version Model NumberPortaKit for D-6 Digital Dialysate Meter
Catalog NumberPKD
Company DUNS064468689
Company NameMYRON L COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-760-438-2021
Emailtechquestions@myronl.com

Device Dimensions

Total Volume2 Fluid Ounce

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857744006221 [Primary]

FDA Product Code

FKHSolution-Test Standard-Conductivity, Dialysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

On-Brand Devices [Myron L® Company]

00857744006221An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case.
00857744006122NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006115NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006108NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006092NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006085NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006078NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006061NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
00857744006054A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP
00857744006047A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP
00857744006030A handheld, multi-function digital device that measures conductivity and temperature of water an
00857744006023A handheld, multi-function digital device that measures conductivity and temperature of water an
00857744006016A handheld, analog instrument that measures conductivity of water and dialysate fluids associate
00857744006009A handheld, analog instrument that measures conductivity of water and dialysate fluids associate

Trademark Results [Myron L]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYRON L
MYRON L
85872725 4435529 Live/Registered
Myron L Company
2013-03-11

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