STAT PROFILE

Basic Information

• Brand Name: STAT PROFILE
• Primary DI: 00385480215138
• Version / Model: pHOx/BASIC
• Catalog Number: 21513
• 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: be33c34f-19a6-42a7-9f70-dc8fbcc19c83

Device Description

STAT PROFILE pHOx/BASIC AIR DETECTOR

Device Characteristics

• Single Use: Yes
• 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
JPK	MIXTURE, HEMATOLOGY QUALITY CONTROL	Hematology	864.8625	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
JKS	Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide	Clinical Toxicology	862.3220	1
JPI	DEVICE, HEMATOCRIT MEASURING	Hematology	864.6400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385480215138	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K014295	000

Storage Conditions

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