Stat Profile

Basic Information

• Brand Name: Stat Profile
• Primary DI: 00385480379595
• Version / Model: CCX
• Catalog Number: 37959
• 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: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 805d9b4a-3a8a-4ea9-b4f3-886d9696ff5f

Device Description

Stat Profile CCX Reference Sensor

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: No
• Has Lot/Batch Number: Yes
• 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
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL	Hematology	864.8625	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN	Clinical Chemistry	862.1770	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
JPI	DEVICE, HEMATOCRIT MEASURING	Hematology	864.6400	2
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide	Clinical Toxicology	862.3220	1
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)	Clinical Chemistry	862.1660	1
CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM	Clinical Chemistry	862.1495	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56667	Metabolic profile clinical chemistry analyser IVD	A portable, electrically-powered automated or semi-automated laboratory instrument 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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385480379595	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020297	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius