StatSensor/StatStrip 53439

GUDID 10385480534397

StatStrip StatSensor Wireless Carrying Case for Meter and Supplies

NOVA BIOMEDICAL CORPORATION

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 10385480534397
• NIH Device Record Key: c05df8da-d9da-4ba2-829c-0dfcfbcb726e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatSensor/StatStrip
• Version Model Number: 1.75
• Catalog Number: 53439
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480534390 [Primary]
GS1	10385480534397 [Package]; Contains: 00385480534390; Package: carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150281

FDA Product Code

• CGL: ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-20

On-Brand Devices [StatSensor/StatStrip]

• 10385480560372: StatStrip Docking Station Remanufactured 4 position 1.75
• 10385480560365: StatStrip Docking Station Remanufactured 2 position 1.75
• 10385480544228: StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
• 10385480544198: StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies
• 10385480534397: StatStrip StatSensor Wireless Carrying Case for Meter and Supplies
• 10385480534021: StatStrip StatSensor Docking Station
• 10385480534014: StatStrip StatSensor Docking Station
• 10385480534007: StatStrip StatSensor Docking Station
• 10385480519967: Statsensor Statstrip Docking Station 4 position
• 10385480519950: Statsensor Statstrip Docking Station 2 position
• 10385480519943: Statsensor Statstrip Docking Station
• 10385480517567: StatSensor StatStrip Docking Station Remanufactured
• 10385480486306: StatSensor StatStrip Wireless Carrying Case for Meter and Supplies
• 10385480486290: StatSensor StatStrip Docking Station for Wireless Carrying Case
• 10385480438060: StatSensor Stat Strip Docking Station Non Network Capable
• 10385480422250: StatSensor StatStrip Docking Station