FreeStyle 12101

GUDID 40699073121019

FreeStyle Blood Glucose Test Strips

ABBOTT DIABETES CARE INC

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 40699073121019
• NIH Device Record Key: d6685a83-a1a8-4886-a997-d4dfc2c5e086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: 12101
• Catalog Number: 12101
• 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(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	00699073121011 [Primary]
GS1	10699073121018 [Unit of Use]
GS1	30699073121012 [Package]; Contains: 00699073121011; Package: Case [12 Units]; In Commercial Distribution
GS1	40699073121019 [Package]; Contains: 00699073121011; Package: Case [12 Units]; In Commercial Distribution
NDC/NHRIC	99073-0121-01 [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: 2016-09-02

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