NOVA 15196

GUDID 00385480151962

NOVA 8 Na+, K+, Ca+, Mg++, pH, Hct

NOVA BIOMEDICAL CORPORATION

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

• Primary Device ID: 00385480151962
• NIH Device Record Key: fb761fdb-f053-4e71-8a61-92efcbda6035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA
• Version Model Number: 8
• Catalog Number: 15196
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-6682
• Email: info@novabio.com
• Phone: +1(800)545-6682
• Email: info@novabio.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480151962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924547

FDA Product Code

• JIX: CALIBRATOR, MULTI-ANALYTE MIXTURE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [NOVA]

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• 10385480539910: Nova 8/8+ Analyzer w/ Printer /Auto Sampler
• 10385480539897: Nova 5/5+ Analyzer w/ Printer
• 10385480539859: Nova 16/16+ Analyzer w/ Ptr / Dilutor
• 10385480539644: Nova 10/10+ Analyzer w/ Printer /Dilutor
• 10385480539637: Nova 10/10+ Analyzer w/ Printer / Primary Tube Auto Sampler
• 10385480500781: Nova Sureflex Lancing Device
• 10385480499603: Nova Sureflex Lancing Device
• 10385480487389: Nova Sureflex Lancets
• 10385480487372: Nova Sureflex 30 Lancets
• 00385480475549: Nova StatStrip LAC Control, Level 2
• 00385480475532: Nova StatStrip LAC Control, Level 1
• 00385480417433: StatStrip StatStrip Xpress GLU Control Level 3
• 00385480417426: StatStrip StatStrip Xpress GLU Control Level 2
• 00385480417419: StatStrip StatStrip Xpress GLU Control Level 1
• 00385480412742: LINEARITY STANDARD SET F
• 10385480282410: NOVA 16 CREATININE MEMBRANE KIT
• 00385480252171: Linearity Standard Set A
• 00385480231312: PO2 INTERNAL FILLING SOLUTION
• 10385480215883: NOVA 16 TCO2 MEMBRANE CAPS
• 00385480186551: NOVA CONTROL 1,2 Na+,K+,Cl-,Ca++,TCO2,GLU,BUN,TCa,Mg++,Li+,pH
• 00385480186544: NOVA CONTROL 3 Na+,K+,Cl-,Ca++,GLU,BUN, TCa,Mg++,Li+,pH
• 00385480183420: NOVA 16 EXTERNAL DILUENT
• 00385480181006: Nova CO-Oximeter Calibrator tHb Control
• 00385480180993: NOVA CO-OXIMETER CONTROL 1,2,3HHb, 02Hb, COHb, Me+, Hb
• 00385480180986: NOVA CO-OXIMETER DEPROTEINIZING SOLUTION
• 00385480178792: NOVA 16 FLOWCELL
• 10385480177556: NOVA 16 CHLORIDE SENSOR CAPS
• 10385480176122: NOVA 16 BUN MEMBRANE KIT
• 00385480175180: NOVA 16 SENSOR MIXER
• 00385480175159: NOVA 16 HEMATOCRIT SENSOR
• 00385480175142: NOVA 16 REFERENCE SENSOR
• 00385480175128: NOVA 16 TCO2 SENSOR
• 00385480175111: NOVA 16 BUN SENSOR
• 00385480175104: NOVA 16 CHLORIDE SENSOR
• 00385480175098: NOVA 16 SODIUM SENSOR
• 00385480174572: NOVA PERFORMANCE CHECK SOLN GLU/BUN/CREAT
• 00385480174527: NOVA 16 CONTROL 1,2,Na+,K+,Cl-,TCO2,GLU,CREAT,BUN,Li+
• 00385480174367: NOVA 16 TCO2 FLOWCELL
• 00385480173643: NOVA 16 POTASSIUM SENSOR
• 00385480173605: NOVA 16 CREATININE SENSOR
• 00385480173599: NOVA 16 GLUCOSE SENSOR
• 00385480172899: NOVA 16 Na+, Cl-, TCo2, Glu, CREAT, BUN,HCt
• 00385480170932: NOVA 16 TUBING HARNESS WITHOUT DILUTOR
• 00385480170925: NOVA 16 TUBING HARNESS WITH DILUTOR
• 00385480167291: NOVA 1/5/11/13 TUBING HARNESS WITH DILUTOR
• 00385480167284: NOVA 1/5/11/13 TUBING HARNESS WITHOUT DILUTOR
• 00385480165013: NOVA 4/10/12 AIR DETECTOR
• 10385480164839: NOVA 16 GLUCOSE MEMBRANE KIT: REFRIGERATE
• 00385480161534: NOVA 12/14 GLU/BUN SENSOR BLANK