FDA.reportPublic FDA data

Stat Profile

Primary DI
10385480642511
Brand
Stat Profile
Company
NOVA BIOMEDICAL CORPORATION
Model
Prime
Catalog number
64251
Device description
Prime Sensor Card CCS Comp 100
Published
2022-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

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
00385480642514PrimaryGS10
10385480642511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480642514003854806425143854806425140385480642514
1038548064251110385480642511

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas/haemoximetry 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 measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.

Sterilization Methods#

Method table
Method

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
true
Serial number
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693930978ABL90 FLEXRadiometer Medical ApSCHL2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699447579SP90Radiometer Medical ApSCHL2026-07-09
05700699461056SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSCHL2026-07-09
05700699461094SC90Radiometer Medical ApSCHL2026-07-09
05700699461100SC90Radiometer Medical ApSCHL2026-07-09
05700699461131SC90Radiometer Medical ApSCHL2026-07-09
05700699461605SC90Radiometer Medical ApSCHL2026-07-09
00054749005673i-STAT G3+ CartridgeAbbott Point of Care Inc.CHL2023-12-18
00385480534437Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480563079Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-08
00385480616218Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-12-07
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONCHL2022-06-16
00385480642514Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-06-06
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2022-06-06
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CHL2020-04-15
00385480614535Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480614542Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623384Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623414Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623421Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623438Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623506Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623513Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03