FreeStyle 70792

GUDID 30699073707926

FreeStyle 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: 30699073707926
• NIH Device Record Key: bc1b2a2b-9d6f-480d-8827-f725b1f9c9da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: 70792
• Catalog Number: 70792
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 50
• 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(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• Email: xx@xx.xx
• Phone: +1(888)522-5226
• 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	00699073707925 [Primary]
GS1	10699073707922 [Unit of Use]
GS1	30699073707926 [Package]; Contains: 00699073707925; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	99073-0707-92 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092638

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-22

On-Brand Devices [FreeStyle]

• 30357599000661: FreeStyle Lancing Device II
• 30699073707926: FreeStyle Blood Glucose Test Strips
• 20699073704324: FreeStyle Control Solution
• 20699073140023: FreeStyle Control Solution
• 30699073130014: FreeStyle Lancets 28 Gauge
• 30699073124501: FreeStyle Blood Glucose Test Strips
• 30699073124013: FreeStyle Blood Glucose Test Strips
• 40699073121019: FreeStyle Blood Glucose Test Strips
• 40699073120500: FreeStyle Blood Glucose Test Strips
• 30093815704288: FreeStyle Unistik 2