OptiScanner 5000 Glucose Monitoring System OPTI-5

GUDID 00850003892504

Automated, in-line, bedside, glucose monitoring system

OPTISCAN BIOMEDICAL CORPORATION

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• Primary Device ID: 00850003892504
• NIH Device Record Key: 85903bd2-c994-4db1-8f6c-a2d72f7da1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiScanner 5000 Glucose Monitoring System
• Version Model Number: 5000
• Catalog Number: OPTI-5
• Company DUNS: 939218384
• Company Name: OPTISCAN BIOMEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com
• Phone: 510.962.6207
• Email: ccastillo@optiscancorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003892504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162042

FDA Product Code

• PYV: Hospital Continuous Glucose Monitoring System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-12-31

Devices Manufactured by OPTISCAN BIOMEDICAL CORPORATION

• 00850003892054 - OptiScanner 5000 Disposable Cartridge: 2019-01-31 OptiScanner Disposable Cartridge
• 00850003892504 - OptiScanner 5000 Glucose Monitoring System: 2019-01-31Automated, in-line, bedside, glucose monitoring system
• 00850003892504 - OptiScanner 5000 Glucose Monitoring System: 2019-01-31 Automated, in-line, bedside, glucose monitoring system