NOVA

Basic Information

• Brand Name: NOVA
• Primary DI: 00385480087964
• Version / Model: 12/14
• Catalog Number: 8796
• Company Name: NOVA BIOMEDICAL CORPORATION
• Labeler DUNS: 070617139
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 866e9f7b-9008-4895-b8bc-e5dba8d9fbfa

Device Description

NOVA 12/14 BUN MEMBRANE KIT

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
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN	Clinical Chemistry	862.1770	2

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
Package	10385480087961	GS1	carton	2	In Commercial Distribution
Primary	00385480087964	GS1
Unit of Use	00385489087965	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius