FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480498470
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX/BASIC/BIOPHOX
Catalog number
49847
Device description
Stat Profile pHOx/Basic/BiopHOx W/R Pump Tubing Kit
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
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKRSYSTEM, HEMOGLOBIN, AUTOMATED
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE
JKSSpectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPIDEVICE, HEMATOCRIT MEASURING
JPKMIXTURE, HEMATOLOGY QUALITY CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GKRSystem, Hemoglobin, AutomatedHematology2
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideClinical Toxicology1
JPIDevice, Hematocrit MeasuringHematology2
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014295000STAT PROFILE PHOX ANALYZERNova Biomedical Corp.2002-02-28CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480498470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480498470003854804984703854804984700385480498470

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.

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
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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

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