ISE Reagent Pack

Basic Information

• Brand Name: ISE Reagent Pack
• Primary DI: 00386100002282
• Version / Model: 5423-0041
• Catalog Number: 5423-0041
• Company Name: MEDICA CORPORATION
• Labeler DUNS: 112942404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-14
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 7e2bb0ee-681f-41ef-8520-fea897e87908

Device Description

ISE Reagent Pack for use with EasyRA 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1
JIH	Flame Photometry, Lithium	Clinical Toxicology	862.3560	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52867	Multiple electrolyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be 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	00386100002282	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070057	000

Storage Conditions

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