PHOENIX DIAGNOSTICS, INC.

Basic Information

• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Primary DI: 00853366007349
• Version / Model: E-340
• 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: 4
• Public Version Date: 2020-03-30
• Public Version Status: Update
• Public Device Record Key: a72b99f4-c115-445e-b616-210f3c500d71

Device Description

Reference Electrode Cartridge for Roche / Hitachi 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: 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
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59241	Reference electrode IVD	An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853366007349	GS1

Premarket Submissions

Submission Number	Supplement Number
K013451	000