FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480364591
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
CCX
Catalog number
36459
Device description
TUBING ASSEMBLIES L1, L2, L3 STP CCX
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDSELECTRODE, ION SPECIFIC, UREA NITROGEN
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CFAELECTRODE, ION SPECIFIC, MAGNESIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GHSASSAY, CARBOXYHEMOGLOBIN
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JKSSpectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPIDEVICE, HEMATOCRIT MEASURING
JPKMIXTURE, HEMATOLOGY QUALITY CONTROL
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CFAElectrode, Ion Specific, MagnesiumClinical Chemistry1
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GHSAssay, CarboxyhemoglobinHematology2
GKRSystem, Hemoglobin, AutomatedHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideClinical Toxicology1
JPIDevice, Hematocrit MeasuringHematology2
JPKMixture, Hematology Quality ControlHematology2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061830000STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+Nova Biomedical Corp.2006-11-01CIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480364591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480364591003854803645913854803645910385480364591

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.

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

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
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10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08718734961093CueSee® Hyperbaric X-HighEurotrol B.V.JJS2021-06-08
08718734960652CueSee® HypoxicEurotrol B.V.JJS2020-10-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
00816068020856Advanced Instruments GloCyte RBC & TNC Verification & Linearity KitAdvanced Instruments, LLCJPK2020-07-21
10054749005519i-STATABBOTT POINT OF CARE INC.CGL2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CGZ2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
10054749005519i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
08058056680532Plasmaproteins Cal 3xSENTINEL CH. SPAJIX2018-11-15
08809301160411Gmate Smart Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-09-17
08809301168011GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168042GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168080GlucoTrack Voice Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168097GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168103GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168127GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168134GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16