FDA.reportPublic FDA data

STAT PROFILE

Primary DI
10385480420133
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX ULTRA CO OX
Catalog number
42013
Device description
Stat Profile pHOx Ultra 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
NGDTEST, LACTIC ACID, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGDTest, Lactic Acid, Over The CounterClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110648000NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEMNova Biomedical Corporation2011-08-29CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480420133PackageGS11In Commercial Distribution
00385480420136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548042013310385480420133
00385480420136003854804201363854804201360385480420136

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 Humidity20 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
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485616STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485630STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485647STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485661Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485678STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485685STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485838STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485845STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485852Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485876Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485883Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485890Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480485944STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480489546Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480489553Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480492041STAT PROFILENOVA BIOMEDICAL CORPORATIONNGD2016-09-20
00385480492058Stat ProfileNOVA BIOMEDICAL CORPORATIONNGD2016-09-16