MEDICA CORPORATION

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Filters

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, Sodium (JGS) (6) Electrode, Ion Specific, Potassium (CEM) (6) Electrode, Ion-Specific, Chloride (CGZ) (4) Electrode, Ion Specific, Calcium (JFP) (4) Instrument, Hematocrit, Automated (GKF) (3) Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (3) Flame Photometry, Lithium (JIH) (2)

Premarket Exempt

No Yes

Clear

Lithium Electrode - 00386100002480 Catalog Number : 4204

Device Description : Lithium Electrode for use with EasyElectrolyte Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH

Prescription Use : Yes

Device Count : 1

Na/K/Cl Analyzer - 00386100002503 Catalog Number : 4002

Device Description : EasyElectrolyte Na/K/Cl Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

EasyElectrolyte Reagent Module, Na/K/Cl Analyzers - 00386100002541 Catalog Number : 4102-0000

Device Description : EasyElectrolyte Reagent Module for Na/K/Cl Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JGS, CEM, CGZ

Prescription Use : Yes

Device Count : 1

EasyElectrolyte Reagent Module, Na/K/Li Analyzers - 00386100002558 Catalog Number : 4103-0000

Device Description : EasyElectrolyte Reagent Module for Na/K/Li Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JIH, CEM, JGS

Prescription Use : Yes

Device Count : 1

pH/pCO2/pO2/Na/K/Ca Analyzer - 00386100002596 Catalog Number : 7001

Device Description : EasyStat pH/pCO2/pO2/Na/K/Ca Analyzer

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Calcium Electrode - 00386100002602 Catalog Number : 7207

Device Description : EasyStat Calcium Electrode for use with EasyStat Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : JFP

Prescription Use : Yes

Device Count : 1

Chloride Electrode - 00386100002619 Catalog Number : 7208

Device Description : EasyStat Chloride Electrode for use with EasyStat Analyzers

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

Product Code : CGZ

Prescription Use : Yes

Device Count : 1

Bi-Level QC Kit, HCT - 00386100002633 Catalog Number : 7309

Device Description : Bi-Level QC Kit, HCT

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Reagent Module - 00386100002664 Catalog Number : 7101-0000

Device Description : EasyStat Reagent Module

Device Class : 2

Duns Number: 112942404

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

ISE Chloride Electrode - 00386100002688 Catalog Number : 5203

Device Description : ISE 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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