FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480536660
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PRIME CCS
Catalog number
53666
Device description
Remanufactured Prime CCS w/ Scanner Analyzer
Published
2017-07-06
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
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKFINSTRUMENT, HEMATOCRIT, AUTOMATED
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GKFInstrument, Hematocrit, 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
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141907000STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ANova Biomedical Corporation2015-05-29CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480536667PackageGS11In Commercial Distribution
00385480536660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548053666710385480536667
00385480536660003854805366603854805366600385480536660

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas analyser IVD, point-of-careA mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Special Storage Condition, Specify000 ft to 12000 ft
Special Storage Condition, Specify00Without Condensation
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius32 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
Serial number
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
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10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
00380740153694AlinityABBOTT LABORATORIESJJS2023-10-14
10852676007121Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007138Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007145Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007152Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007169Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
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10852676007190Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007206Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007213Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
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08718734961093CueSee® Hyperbaric X-HighEurotrol B.V.JJS2021-06-08
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
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