SelectaLyte (Sodium Electrode)

Basic Information

• Brand Name: SelectaLyte (Sodium Electrode)
• Primary DI: 00850229007324
• Version / Model: 3910
• Company Name: AWARENESS TECHNOLOGY, INCORPORATED
• Labeler DUNS: 071065130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-26
• Public Version: 1
• Public Version Date: 2019-07-04
• Public Version Status: New
• Public Device Record Key: c6a3eabe-aa7e-4e63-9a7e-8eb0ffe8c6fd

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: No
• Has Manufacturing Date: No
• 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
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52866	Multiple electrolyte IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes 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	00850229007324	GS1

Premarket Submissions

Submission Number	Supplement Number
K171476	000