OptiumEZ 71065

GUDID 30093815710654

Optium EZ Blood Glucose Monitoring System

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use

• Primary Device ID: 30093815710654
• NIH Device Record Key: 343b1517-2bad-468a-ab0e-014b49dc68e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiumEZ
• Version Model Number: 71065
• Catalog Number: 71065
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx
• Phone: +1(800)527-3339
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815710653 [Primary]
GS1	30093815710654 [Package]; Contains: 00093815710653; Package: Case [30 Units]; In Commercial Distribution
NDC/NHRIC	57599-1065-1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081975

FDA Product Code

• NBW: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-26
• Device Publish Date: 2016-08-12

On-Brand Devices [OptiumEZ]

• 30093815710654: Optium EZ Blood Glucose Monitoring System
• 30093815710425: Optium EZ Blood Glucose Test Strips
• 30093815710418: Optium EZ Blood Glucose Test Strips