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 Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (5) Electrode, Ion Specific, Potassium (CEM) (3) Electrode, Ion Specific, Sodium (JGS) (3) Electrode, Ion-Specific, Chloride (CGZ) (2) Flame Photometry, Lithium (JIH) (1) Glucose Oxidase, Glucose (CGA) (1) Instrument, Hematocrit, Automated (GKF) (1) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Assay, Glycosylated Hemoglobin (LCP) (1) Calibrator, Secondary (JIT) (1) Electrode, Ion Specific, Calcium (JFP) (1)

Premarket Exempt

No Yes

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HbA1c Reagent Kit - 00386100002268 Catalog Number : 10230-2

Device Description : HbA1c Reagent Kit for use with EasyRA Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

ISE Reagent Pack - 00386100002282 Catalog Number : 5423-0041

Device Description : ISE Reagent Pack for use with EasyRA Analyzers

Device Class : 1

Duns Number: 112942404

Premarket Exempt : No

Product Code : JJY, JIT, JJE, JIH, CGZ, CEM, JGS, CGA

Prescription Use : Yes

Device Count : 1

EasyBloodGas Analyzer - 00386100002299 Catalog Number : 6001

Device Description : EasyBloodGas Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

pH Electrode - 00386100002305 Catalog Number : 6201

Device Description : pH electrode for use with EasyBloodGas and EasyStat analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

pCO2 electrode - 00386100002312 Catalog Number : 6202

Device Description : pCO2 electrode for use with EasyBloodGas and EasyStat Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

pO2 Electrode - 00386100002329 Catalog Number : 6203

Device Description : pO2 electrode for use with EasyBloodGas and EasyStat Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Daily Cleaning Solution Kit - 00386100002398 Catalog Number : 2118

Device Description : Daily Cleaning Solution Kit for use with EasyStat, EasyBloodGas, EasyLyte and Ea Daily Cleaning Solution Kit for use with EasyStat, EasyBloodGas, EasyLyte and EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CEM, JGS, JFP, GKF, CHL

Prescription Use : Yes

Device Count : 1

Sodium Electrode - 00386100002459 Catalog Number : 7205

Device Description : Sodium electrode for use with EasyStat and EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS

Prescription Use : Yes

Device Count : 1

Potassium Electrode - 00386100002466 Catalog Number : 7206

Device Description : Potassium Electrode for use with EasyStat and EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CEM

Prescription Use : Yes

Device Count : 1

Chloride Electrode - 00386100002473 Catalog Number : 4203

Device Description : Chloride Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CGZ

Prescription Use : Yes

Device Count : 1

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