PHOENIX DIAGNOSTICS, INC.

Basic Information

• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Primary DI: 00853366007110
• Version / Model: E-910
• Company Name: PHOENIX DIAGNOSTICS, INC.
• Labeler DUNS: 606814960
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-26
• Public Version: 5
• Public Version Date: 2020-11-18
• Public Version Status: Update
• Public Device Record Key: c89a9c91-8bc4-4410-b74f-556a5f202745

Device Description

K+ Electrode for Olympus AU Series Chemistry Systems

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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	00853366007110	GS1

Premarket Submissions

Submission Number	Supplement Number
K020148	000