Myron L® Company

Basic Information

• Brand Name: Myron L® Company
• Primary DI: 00857744006016
• Version / Model: D-2 Dialysate Meter™
• Catalog Number: D-2
• Company Name: MYRON L COMPANY
• Labeler DUNS: 064468689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1dce6d5e-ad5b-45a0-9162-4cf191b2938e

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLB	Meter, Conductivity, Induction, Remote Type	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35001	Multi-parameter device tester	A 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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857744006016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Feeze
• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius