Myron L® Company D-4

GUDID 00857744006023

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. 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: 00857744006023
• NIH Device Record Key: 5484e174-2675-434c-bdd2-ae20962f6b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myron L® Company
• Version Model Number: D-4 Digital Dialysate Meter™
• Catalog Number: D-4
• Company DUNS: 064468689
• Company Name: MYRON L COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857744006023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100237

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Myron L® Company]

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• 00857744006108: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 00857744006092: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 00857744006085: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 00857744006078: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 00857744006061: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
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• 00857744006047: A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP
• 00857744006030: A handheld, multi-function digital device that measures conductivity and temperature of water an
• 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