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 ID: 00857744006221
• NIH Device Record Key: 7222b365-5068-4dcf-b850-a23778946779
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myron L® Company
• Version Model Number: PortaKit for D-6 Digital Dialysate Meter
• Catalog Number: PKD
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

• Total Volume: 2 Fluid Ounce

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857744006221 [Primary]

FDA Product Code

• FKH: Solution-Test Standard-Conductivity, Dialysis

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]

• 00857744006221: An accessory for the D-6 Dialysate Meter™. A hard case, foam-lined protective carrying case.
• 00857744006122: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 00857744006115: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predo
• 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
• 00857744006054: A handheld, multi-function, digital device that measures conductivity, pH, Temperature, and ORP
• 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