FDA.reportPublic FDA data

NOVA

Primary DI
00385480068574
Brand
NOVA
Company
NOVA BIOMEDICAL CORPORATION
Model
1
Catalog number
6857
Device description
Nova PCO2/TCO2 Conditioning Solution
Published
2016-09-16
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
JFLPH RATE MEASUREMENT, CARBON-DIOXIDE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963005000NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)Nova Biomedical Corp.1996-08-23JFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385480068574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385480068574003854800685743854800685740385480068574

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
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
10054749005519i-STATABBOTT POINT OF CARE INC.JFL2020-05-01
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
00385480626446Stat ProfileNOVA BIOMEDICAL CORPORATIONCHL2020-02-03