FDA.reportPublic FDA data

STAT PROFILE

Primary DI
10385480375556
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
CCX CO OX
Catalog number
37555
Device description
Remanufactured Stat Profile Critical Care Xpress 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
JPIDEVICE, HEMATOCRIT MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPIDevice, Hematocrit MeasuringHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061830000STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+Nova Biomedical Corp.2006-11-01CIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480375556PackageGS11In Commercial Distribution
00385480375559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548037555610385480375556
00385480375559003854803755593854803755590385480375559

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005519i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
00054749005512i-STATABBOTT POINT OF CARE INC.JPI2020-05-01
00385480167291NOVANOVA BIOMEDICAL CORPORATIONJPI2017-04-24
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJPI2017-04-24
10873037000766StatSpinIRIS INTERNATIONAL, INC.JPI2016-09-24
10873037000216StatSpinBECKMAN COULTER IRELAND INC.JPI2016-09-24
04050674030410Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674030427Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674030441Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
04050674077675Rotor 24 place for capillariesAndreas Hettich GmbHJPI2016-09-24
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-22
00385480132114NovaNOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480141567NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480152150NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480239622STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480278034STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480322041STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480340816STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480347174STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480355360STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480380256STAT PROFILENOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539890NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539913NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20
00385480539920NOVANOVA BIOMEDICAL CORPORATIONJPI2016-09-20