STAT PROFILE

Basic Information

• Brand Name: STAT PROFILE
• Primary DI: 00385480420136
• Version / Model: PHOX ULTRA CO OX
• Catalog Number: 42013
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 956dc1f6-30b1-4c61-8941-3b78a5b26391

Device Description

Stat Profile pHOx Ultra Co-Oximeter Analyzer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGD	TEST, LACTIC ACID, OVER THE COUNTER	Clinical Chemistry	862.1450	1
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
GKK	CYANOMETHEMOGLOBIN	Hematology	864.7500	2
GJC	ASSAY, SULFHEMOGLOBIN	Hematology	864.7490	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM	Clinical Chemistry	862.1495	1
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)	Clinical Chemistry	862.1115	1
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
GLY	OXIMETER TO MEASURE HEMOGLOBIN	Hematology	864.7500	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
GGZ	OXYHEMOGLOBIN	Hematology	864.7500	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN	Clinical Chemistry	862.1770	2
BXX	CALIBRATOR, PRESSURE, GAS	Anesthesiology	868.2620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56668	Metabolic profile clinical chemistry analyser IVD, portable, semi-automated	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10385480420133	GS1	Box	1	In Commercial Distribution
Primary	00385480420136	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K110648	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Without Condensation
• Type: Special Storage Condition, Specify
• Special Conditions: 0 ft to 15000 ft
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 85 Percent (%) Relative Humidity