OptiumEZ 71042

GUDID 30093815710425

Optium EZ Blood Glucose Test Strips

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: 30093815710425
• NIH Device Record Key: b71c992e-b476-4f51-b20f-74c86fc00789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiumEZ
• Version Model Number: 71042
• Catalog Number: 71042
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 100
• 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: false
• Expiration Date: true
• 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 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00093815710424 [Primary]
GS1	10093815710421 [Unit of Use]
GS1	30093815710425 [Package]; Contains: 00093815710424; Package: Case [6 Units]; In Commercial Distribution
NDC/NHRIC	57599-1042-5 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081975

FDA Product Code

• LFR: Glucose dehydrogenase, glucose

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: 2016-07-22

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