FreeStyle Libre 2 71992

GUDID 30357599800001

FreeStyle Libre 2 Flash Glucose Monitoring System Sensor

ABBOTT DIABETES CARE INC

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• Primary Device ID: 30357599800001
• NIH Device Record Key: 0b85c124-3b28-4cd5-9cdf-d71d5eb89a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Libre 2
• Version Model Number: 71992
• Catalog Number: 71992
• Company DUNS: 966390890
• Company Name: ABBOTT DIABETES CARE INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599800000 [Primary]
GS1	30357599800001 [Package]; Contains: 00357599800000; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193371

FDA Product Code

• QLG: Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [FreeStyle Libre 2]

• 30357599804009: FreeStyle Libre 2 Flash Glucose Monitoring System Reader
• 30357599803002: FreeStyle Libre 2 Flash Glucose Monitoring System Reader
• 30357599801008: FreeStyle Libre 2 Flash Glucose Monitoring System Sensor
• 30357599800001: FreeStyle Libre 2 Flash Glucose Monitoring System Sensor
• 30357599805006: FreeStyle Libre 2 Flash Glucose Monitoring System Reader