Lingo 78797-01

GUDID 30357599853007

Lingo Glucose Biosensor

ABBOTT DIABETES CARE INC

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

• Primary Device ID: 30357599853007
• NIH Device Record Key: 96cbecfe-2129-4f30-b46c-878ccad145d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lingo
• Version Model Number: 78797-01
• Catalog Number: 78797-01
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com
• Phone: +1(888)764-7684
• Email: lingosupport-us@hellolingo.com

Operating and Storage Conditions

• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	30357599853007 [Primary]

FDA Product Code

• SAF: Integrated continuous glucose monitor for non-intensive glucose monitoring, Over-The-Counter

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: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [Lingo]

• 30357599853007: Lingo Glucose Biosensor
• 30357599848003: Lingo Glucose Biosensor
• 00357599853006: Lingo Glucose Biosensor
• 00357599849009: Lingo Biosensor iOS App US
• 00357599848002: Lingo Glucose Biosensor
• 00357599852009: Lingo Glucose Biosensor