Potassium Electrode

Basic Information

• Brand Name: Potassium Electrode
• Primary DI: 03661540304156
• Version / Model: 279-001
• Catalog Number: 279-001
• Company Name: ELITECHGROUP INC.
• Labeler DUNS: 052423787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-01
• Public Version: 2
• Public Version Date: 2024-08-05
• Public Version Status: Update
• Public Device Record Key: db07ab70-8be1-429c-a346-ef1d8777490f

Device Description

ISE electrode for the measurement of Potassium in IVD samples.

Device Characteristics

• Single Use: No
• 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
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52892	Potassium (K+) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen, using an ion-selective electrode (ISE) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540304156	GS1

Customer Contacts

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