MesaLabs

Basic Information

• Brand Name: MesaLabs
• Primary DI: M9850200270
• Version / Model: 02.0027
• Catalog Number: 02.0027
• Company Name: MESA LABORATORIES, INC.
• Labeler DUNS: 102530326
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 721cdfdd-ad82-4fb9-98c1-b9132e979aaa

Device Description

Conductivity Standard Solution 14.0 mS/cm 1 qt

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FKH	Solution-Test Standard-Conductivity, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47678	Haemodialysis conductivity standard solution	A salt solution, typically salt dissolved in deionized/purified water, used to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. The solution is typically available in sealed plastic bottles and in a range of values and accuracies. It may be available over-the-counter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M9850205101	HIBCC	Carton	6	In Commercial Distribution
Primary	M9850200270	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K033330	000