Myron L® Company D-2

GUDID 00857744006016

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.

MYRON L COMPANY

Multi-parameter device tester

• Primary Device ID: 00857744006016
• NIH Device Record Key: 1dce6d5e-ad5b-45a0-9162-4cf191b2938e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myron L® Company
• Version Model Number: D-2 Dialysate Meter™
• Catalog Number: D-2
• Company DUNS: 064468689
• Company Name: MYRON L COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-760-438-2021
• Email: techquestions@myronl.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857744006016 [Primary]

FDA Product Code

• FLB: Meter, Conductivity, Induction, Remote Type

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Myron L® Company]

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• 00857744006061: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
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• 00857744006023: A handheld, multi-function digital device that measures conductivity and temperature of water an
• 00857744006016: A handheld, analog instrument that measures conductivity of water and dialysate fluids associate
• 00857744006009: A handheld, analog instrument that measures conductivity of water and dialysate fluids associate