FreeStyle Libre 14 day 71938

GUDID 57599-0002-00

FreeStyle Libre 14 day Reader Kit US

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system

• Primary Device ID: 57599-0002-00
• NIH Device Record Key: 362f7c3e-a17f-4f10-959c-49bcb5e6ad4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Libre 14 day
• Version Model Number: 71938
• Catalog Number: 71938
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• Phone: +1(855)632-8658
• Email: xx@xx.xx
• Phone: +1(855)632-8658
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599002008 [Primary]
GS1	30357599002009 [Package]; Contains: 00357599002008; Package: [4 Units]; In Commercial Distribution
NDC/NHRIC	57599-0002-00 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160030

FDA Product Code

• PZE: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-22
• Device Publish Date: 2019-08-14

On-Brand Devices [FreeStyle Libre 14 day]

• 30357599001026: FreeStyle Libre 14 day Sensor Kit NFRS
• 30357599001019: FreeStyle Libre 14 day Sensor Kit
• 30357599002009: FreeStyle Libre 14 day Reader Kit US
• 30357599000975: FreeStyle Libre 14 day Reader Kit US, NFRS
• 30357599000982: FreeStyle Libre 14 day Reader Kit US DOD
• 57599-0002-00: FreeStyle Libre 14 day Reader Kit US
• 57599-0000-97: FreeStyle Libre 14 day Reader Kit US