FDA.reportPublic FDA data

STAT PROFILE

Primary DI
10385480333433
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX CO OX
Catalog number
33343
Device description
Remanufactured Stat Profile pHOx CO-Oximeter Analyzer
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GLYOXIMETER TO MEASURE HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLYOximeter To Measure HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993104000STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORNova Biomedical Corp.1999-12-02GLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480333433PackageGS11In Commercial Distribution
00385480333436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548033343310385480333433
00385480333436003854803334363854803334360385480333436

GMDN Terms#

Term, Definition table
TermDefinition
Co-oximetry analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify000 ft to 15000 ft
Special Storage Condition, Specify00Without Condensation
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08426950807711GEM Premier 5000 PAK BG/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
08426950807735GEM Premier 5000 PAK BG/ISE/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
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08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
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08426950807810GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
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08426950899662GEM Premier 5000 PAK BG/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
00385480333436STAT PROFILENOVA BIOMEDICAL CORPORATIONGLY2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONGLY2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONGLY2016-09-20