Myron L® Company

Basic Information

• Brand Name: Myron L® Company
• Primary DI: 00857744006030
• Version / Model: D-4 Digital Dialysate Meter™, bluDock Capable
• Catalog Number: D-4BD
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 63181245-927f-4f41-b935-d23554da6ff7

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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	00857744006030	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100237	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Freeze
• Type: Storage Environment Temperature
• Temperature Range: 0 – 55 Degrees Celsius