FDA.reportPublic FDA data

NOVA

Primary DI
00385480147132
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
1/4/5/8/10/11/12/13/14
Catalog number
14713
Device description
NOVA 1/4/5/8/10/11/12/13/14 POTASSIUM SENSOR
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480147132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480147132003854801471323854801471320385480147132

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, semi-automatedA portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-6682info@novabio.com

Regulatory Flags#

DUNS number
070617139
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
00385480657365StatSensor StatStripGen 2.0657362026-05-06
00385480667678StatSensor StatStripGeen 2.0667672026-05-06
00385480667685StatSensor StatStripGen 2.0667682026-05-06
10385480632307Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480533980STATSTRIP1.75533982016-09-20
00385480533997STATSTRIP1.75533992016-09-20
00385480547901STATSTRIP1.86547902016-09-16
00385480636858StatStrip63685636852024-03-28
10385480534939NOVAMAX PLUS KETONE534932016-09-20
00385480434355Nova MaxPlus434352016-09-20
00385480434362Nova MaxPlus434362016-09-20
00385480458245Nova MaxPlus458242016-09-20
20385480534936NOVAMAX PLUS KETONE534932016-09-20
10385480631645Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
10385480631652Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
10385480631669Nova Primary Nova Primary Linearity Level 2631662023-02-24
00385480631648Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
00385480631655Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
00385480631662Nova Primary Nova Primary Linearity Level 2631662023-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CEM2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCEM2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCEM2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003043Na/K/Cl Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONCEM2018-12-04