MEDICA CORPORATION

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Ion Specific, Potassium (CEM) (9) Electrode, Ion Specific, Sodium (JGS) (9) Electrode, Ion-Specific, Chloride (CGZ) (7) Flame Photometry, Lithium (JIH) (3) Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (1) Electrode, Ion Specific, Calcium (JFP) (1)

Premarket Exempt

No Yes

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ISE eChloride Electrode - 00386100002695 Catalog Number : 5207

Device Description : ISE eChloride Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CGZ

Prescription Use : Yes

Device Count : 1

ISE Cleaning Solution Kit - 00386100002794 Catalog Number : 5421

Device Description : ISE Cleaning Solution Kit for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

ISE Reagent Pack - 00386100002817 Catalog Number : 5420-0000

Device Description : ISE Reagent Pack for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

ISE Reagent Module - 00386100002831 Catalog Number : 5425-0000

Device Description : ISE Reagent Module for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

Na/K Analyzer - 00386100002862 Catalog Number : 2004

Device Description : EasyLyte Na/K Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CEM, JGS

Prescription Use : Yes

Device Count : 1

Na/K/Cl Analyzer - 00386100002879 Catalog Number : 2014

Device Description : EasyLyte Plus Na/K/Cl Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CGZ, CEM, JGS

Prescription Use : Yes

Device Count : 1

Lithium Na/K/Li Analyzer - 00386100002886 Catalog Number : 2015

Device Description : EasyLyte Lithium Na/K/Li Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH, CEM, JGS

Prescription Use : Yes

Device Count : 1

Calcium Na/K/Ca/pH Analyzer - 00386100002893 Catalog Number : 2016

Device Description : EasyLyte Calcium Na/K/Ca/pH Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHL, JGS, CEM, JFP

Prescription Use : Yes

Device Count : 1

Na/K/Cl/Li Analyzer - 00386100002909 Catalog Number : 2021

Device Description : EasyLyte Na/K/Cl/Li Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH, CEM, JGS, CGZ

Prescription Use : Yes

Device Count : 1

Na/K/Cl/Li Solution Pack - 00386100002916 Catalog Number : 2026

Device Description : Na/K/Cl/Li Solution Pack for use with EasyLyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH, CEM, JGS, CGZ

Prescription Use : Yes

Device Count : 1

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