Potassium Electrode

Basic Information

• Brand Name: Potassium Electrode
• Primary DI: 00386100002961
• Version / Model: 2101
• Catalog Number: 2101
• Company Name: MEDICA CORPORATION
• Labeler DUNS: 112942404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-08
• Public Version: 1
• Public Version Date: 2018-12-10
• Public Version Status: New
• Public Device Record Key: 21495e83-d40c-4c36-9972-4abaf86522fc

Device Description

ISE Potassium Electrode for use with EasyLyte analyzers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
59248	Potassium (K+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386100002961	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K864872	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius