OptiScanner 5000 Disposable Cartridge

GUDID 00850003892054

OptiScanner Disposable Cartridge

OPTISCAN BIOMEDICAL CORPORATION

Point-of-care blood glucose continuous monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system Point-of-care blood glucose monitoring system

• Primary Device ID: 00850003892054
• NIH Device Record Key: 7179050a-2c2e-4d0a-814c-4fc71f242993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiScanner 5000 Disposable Cartridge
• Version Model Number: 5000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com
• Phone: 510.342.5818
• Email: edeperalta@optiscancorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to rain or water
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003892054 [Primary]
GS1	10850003892051 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	20850003892058 [Package]; Contains: 10850003892051; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162042

FDA Product Code

• PYV: Hospital Continuous Glucose Monitoring System

Sterilization

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

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

[00850003892054]

Radiation Sterilization

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