Livongo Blood Glucose Meter FG02062

GUDID 00853553005349

Blood Glucose Meter

LIVONGO HEALTH, INC

Glucose analyser IVD, home-use

• Primary Device ID: 00853553005349
• NIH Device Record Key: b9534762-ba4e-48d9-a1ed-0ca0920cfde7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Blood Glucose Meter
• Version Model Number: BG300
• Catalog Number: FG02062
• Company DUNS: 829984561
• Company Name: LIVONGO HEALTH, INC
• Device Count: 1
• 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: false
• 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: true

Customer Support Contacts

• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com
• Phone: 800.945.4355
• Email: membersupport@livongo.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-21

On-Brand Devices [Livongo Blood Glucose Meter]

• 00853553005349: Blood Glucose Meter
• 00853553005288: Livongo BG300 Blood Glucose Meter
• 00853553005196: Livongo BG300 Blood Glucose Meter
• 00853553005011: BG300 rev C Blood Glucose Meter, Kaifa DongGuan