Livongo Replacement Device KIT01595

GUDID 00853553005417

Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)

LIVONGO HEALTH, INC

Glucose analyser IVD, home-use

• Primary Device ID: 00853553005417
• NIH Device Record Key: c97dc761-4643-4f20-bc9c-21215b91608c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Replacement Device
• Version Model Number: Livongo
• Catalog Number: KIT01595
• 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

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
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005417 [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 Replacement Device]

• 00853553005417: Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide
• 00853553005301: BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide (Spanish)
• 00853553005240: Livongo Blood Glucose Meter BG300, Charger, Charger Cable, 1 User Guide (English), 1 User Guide