FDA.reportPublic FDA data

StatSensor

Primary DI
10385480453353
Brand
StatSensor
Company
NOVA BIOMEDICAL CORPORATION
Model
1.0
Catalog number
45335
Device description
StatSensor Creatinine Meter with Quick Reference Guide - Remanufactured
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
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070068000NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.2007-05-07CGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480453353PackageGS11In Commercial Distribution
00385480453356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548045335310385480453353
00385480453356003854804533563854804533560385480453356

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 Celsius40 Degrees Celsius
Special Storage Condition, Specify000 ft to 15000 ft
Special Storage Condition, Specify00Without Condensation
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius40 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005519i-STATABBOTT POINT OF CARE INC.CGL2020-05-01
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSCGL2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSCGL2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSCGL2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSCGL2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSCGL2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSCGL2018-09-21
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCGL2017-04-24
10385480433706STATSENSORNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
10385480528006STATSENSORNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480282413NOVANOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480422253StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480438063StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480440523StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480453356StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486293StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480486309StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480506687StatSensorNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480517560StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519946StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20
00385480519953StatSensor/StatStripNOVA BIOMEDICAL CORPORATIONCGL2016-09-20