Livongo Welcome Kit KIT00801

GUDID 00853553005295

BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish)

LIVONGO HEALTH, INC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00853553005295
• NIH Device Record Key: b8e99c2b-ecc2-4787-94dd-8a3bdd24d067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Welcome Kit
• Version Model Number: Livongo G2.0FW2.1
• Catalog Number: KIT00801
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: 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 Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 75 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005295 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-02

On-Brand Devices [Livongo Welcome Kit ]

• 00853553005400: BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Contr
• 00853553005295: BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Contr
• 00853553005257: Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile L
• 00853553005233: Livongo Welcome Kit G2.0 with BG300, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile L