FDA.reportPublic FDA data

ISE Sodium electrode

Primary DI
00386100001636
Brand
ISE Sodium electrode
Company
MEDICA CORPORATION
Model
5201
Catalog number
5201
Device description
ISE Sodium Electrode for use with EasyElectrolyte Analyzers
Published
2018-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000926000EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMedica Corp.2000-05-15CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100001636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100001636003861000016363861000016360386100001636

GMDN Terms#

Term, Definition table
TermDefinition
Sodium (Na+) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386100002145ALB Reagent Kit10218-410218-42019-02-14
00386100002008CHOL Reagent Kit 10204-410204-42019-02-14
00386100002022SGOT (AST) Reagent Kit10206-410206-42019-02-14
00386100002039TBIL Reagent Kit10207-410207-42019-02-14
00386100002053CO2 Reagent Kit 10209-410209-42019-02-14
00386100002060Ca Reagent Kit 10210-410210-42019-02-14
00386100002077HDL CHOL Reagent Kit10211-410211-42019-02-14
00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
00386100002121TRIG Reagent Kit10216-410216-42019-02-14
00386100002138AMY Reagent Kit10217-410217-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONJGS2022-06-16
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-06-06
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.JGS2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESJGS2019-10-31
00380740163372ARCHITECTAbbott GmbHJGS2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONJGS2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJGS2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJGS2019-02-14
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJGS2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONJGS2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONJGS2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJGS2018-12-04
00386100002862Na/K AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJGS2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJGS2018-12-04
00386100002985Reference ElectrodeMEDICA CORPORATIONJGS2018-12-04
00386100003029Na/K Solution PackMEDICA CORPORATIONJGS2018-12-04