FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480485913
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX ULTRA/CCX
Catalog number
48591
Device description
Stat Profile pHOx Ultra/CCX SO2 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
JKSSpectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110648000NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMNova Biomedical Corporation2011-08-29CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480485913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480485913003854804859133854804859130385480485913

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
00385480097987STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2017-12-19
10711234530245Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
10711234530252Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
10711234530276Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
08426950490791GEM OPL (220V)INSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950088684GEM OPL CUVETTESINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950452577GEM OPL (110V)INSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950452614TEMPERATURE PROBEINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950813590OPTICAL QC FILTERSINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
10711234160039Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234160046Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234160053Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234530054Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-22
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480239622STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480340816STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480347174STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480355360STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480380256STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480214971STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215121STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215138STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215190STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215206STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480225076STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20