Stat Profile 52714

GUDID 00385480527149

Stat Profile Prime Ampuled Control ABG/CCS

NOVA BIOMEDICAL CORPORATION

Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

• Primary Device ID: 00385480527149
• NIH Device Record Key: 06413b0d-0557-46b8-96cb-28d474ab23fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stat Profile
• Version Model Number: Prime ABG/CCS
• Catalog Number: 52714
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 30
• 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: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480527149 [Primary]
GS1	00385489527140 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151982

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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 [Stat Profile]

• 10385480616154: Stat Profile Prime Plus MicroSensor Card™ with COOX
• 10385480616147: Stat Profile Prime Plus MicroSensor Card™ with COOX (High Volume)
• 10385480595084: Stat Profile Prime Plus® Analyzer (Remanufactured)
• 10385480586433: Stat Profile Prime Plus MicroSensor Card™ (High Volume)
• 10385480586426: Stat Profile Prime Plus MicroSensor Card™
• 10385480583791: Stat Profile Prime Plus MicroSensor Card™ BLANK
• 00385480578455: Stat Profile Prime Plus Ampuled Controls Chemistry Levels 4,5
• 00385480578448: Stat Profile Prime Plus Ampuled Controls BG, COOX Levels 1, 2, 3
• 00385480578431: Stat Profile Prime Plus Auto QC Cartridge 315 Sample with Creat / BUN
• 00385480578424: Stat Profile Prime Plus Auto QC Cartridge 210 Sample with Creat / BUN
• 00385480578417: Stat Profile Prime Plus Auto QC Cartridge 105 Sample with Creat / BUN
• 00385480578400: Stat Profile Prime Plus Auto QC Cartridge 480 Sample
• 00385480578394: Stat Profile Prime Plus Auto QC Cartridge 320 Sample
• 00385480578387: Stat Profile Prime Plus Auto QC Cartridge 160 Sample
• 00385480578356: Stat Profile Prime Plus Calibrator Cartridge 500 Sample with Creat / BUN
• 00385480578349: Stat Profile Prime Plus Calibrator Cartridge 400 Sample with Creat / BUN
• 00385480578332: Stat Profile Prime Plus Calibrator Cartridge 300 Sample with Creat / BUN
• 00385480578325: Stat Profile Prime Plus Calibrator Cartridge 200 Sample with Creat / BUN
• 00385480578318: Stat Profile Prime Plus Calibrator Cartridge 100 Sample with Creat / BUN
• 00385480578295: Stat Profile Prime Plus Calibrator Cartridge 500 Sample
• 00385480578288: Stat Profile Prime Plus Calibrator Cartridge 400 Sample
• 00385480578271: Stat Profile Prime Plus Calibrator Cartridge 300 Sample
• 00385480578264: Stat Profile Prime Plus Calibrator Cartridge 200 Sample
• 00385480578257: Stat Profile Prime Plus Calibrator Cartridge 100 Sample
• 00385480578233: Stat Profile Prime Plus Reference Cartridge
• 10385480578216: Stat Profile Prime Plus MicroSensor Card™ BUN, Creatinine
• 10385480574003: Stat Profile Prime Plus® Analyzer
• 00385480567268: Prime Capillary Tube 150 uL with Balanced Heparin 250 per vial
• 00385480567251: Prime Capillary Tube 230 uL with Balanced Heparin 250 per vial
• 00385480561983: Linearity Standard Set G Multipack
• 10385480552643: Prime Sensor Card CCS Comp (High Volume)
• 10385480552636: Prime Sensor Card CCS (High Volume)
• 10385480552629: Prime Sensor Card ABG (High Volume)
• 00385480536677: Remanufactured Prime CCS Comp w/ Scanner Analyzer
• 00385480536660: Remanufactured Prime CCS w/ Scanner Analyzer
• 00385480536653: Remanufactured Prime ABG w/ Scanner Analyzer
• 00385480536578: Prime CCS Comp w/ Scanner Analyzer
• 00385480536561: Prime CCS w/ Scanner Analyzer
• 00385480536554: Prime ABG w/ Scanner Analyzer
• 10385480534694: Prime Calibrator Cartridge CCS Comp 500 Sample
• 00385480534673: Prime Calibrator Cartridge CCS 500 Sample
• 00385480534666: Prime Calibrator Cartridge CCS 400 Sample
• 00385480534642: Prime Calibrator Cartridge ABG 500 Sample
• 00385480534635: Prime Calibrator Cartridge ABG 400 Sample
• 00385480534567: Prime Auto QC Cartridge ABG 100 Sample
• 00385480534550: Prime Auto QC Cartridge CCS 100 Sample
• 00385480534215: Remanufactured PRIME ABG Analyzer
• 00385480534208: Remanufactured PRIME CCS Comp Analyzer
• 00385480534185: Remanufacture PRIME CCS Analyzer
• 00385480533652: Prime Calibrator Cartridge CCS Comp 200 Sample