FreeStyle Libre 14 day 71939

GUDID 30357599001026

FreeStyle Libre 14 day Sensor Kit NFRS

ABBOTT DIABETES CARE INC

Percutaneous glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 30357599001026
• NIH Device Record Key: 534a7f7b-8484-4426-9844-f58d619bab95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Libre 14 day
• Version Model Number: 71939
• Catalog Number: 71939
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70000 KiloPascal and 106000 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357599001025 [Primary]
GS1	30357599001026 [Package]; Contains: 00357599001025; Package: Case [24 Units]; In Commercial Distribution
NDC/NHRIC	57599-0001-02 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-10-10

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• 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