FDA.reportPublic FDA data

Sodium Electrode

Primary DI
00811403010165
Brand
Sodium Electrode
Company
Diamond Diagnostics Inc.
Model
AV-BP0413D
Device description
Measuring concentration of Sodium in whole blood, serum, plasma, and diluted urine samples.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403010165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403010165008114030101658114030101650811403010165

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403011469Glucose Electrode MembraneBK-670597D2023-06-12
00811403011667Glucose ReagentBK-472500D2023-06-12
00811403011636Glucose ElectrodeBK-469499D2023-06-10
00811403011131Glucose Reagent BK-443355D2023-06-05
00811403011605Albumin ReagentBK-467858D2023-06-10
00811403015504Maintenance KitHM-XEA328ASD2023-06-13
00811403015511O-Ring KitHM-XEA486ORD2023-06-13
00811403018901Vaccuum Pump Rebuild KitCO-67030079D2023-06-13
00811403019045Compressor Rebuild KitSX-28144879D2023-06-13
00811403019052Compressor Rebuild KitSX-44368656D2023-06-13
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+0-DD-SMARTLYTEPLUS2023-06-05
00811403013289Wash PackCD-473497D2023-06-13
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13

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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