FreeStyle InsuLinx 71227

GUDID 30699073712272

FreeStyle InsuLinx Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use 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: 30699073712272
• NIH Device Record Key: 6bc66ae9-70ed-467c-8534-bc33fa8cad1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle InsuLinx
• Version Model Number: 71227
• Catalog Number: 71227
• 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)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx
• Phone: +1(800)222-3100
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699073712271 [Primary]
GS1	10699073712278 [Unit of Use]
GS1	30699073712272 [Package]; Contains: 00699073712271; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	99073-0712-27 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152328

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

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