FDA.reportPublic FDA data

STAT PROFILE

Primary DI
10385480420317
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
Prime ABG
Catalog number
42031
Device description
Prime Sensor Card ABG
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
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
K151982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151982000Stat Profile Prime ABG Analyzer SystemNova Biomedical Corporation2015-09-10CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480420317PackageGS11In Commercial Distribution
00385480420310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548042031710385480420317
00385480420310003854804203103854804203100385480420310

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 Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
00630414606460epoc Host2Epocal IncCHL2020-07-15
00630414606095epoc NXS HostEpocal IncCHL2020-06-18
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
00385480623520Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480623537Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626323Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626347Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626361Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626385Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626408Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03
00385480626422Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03