In Touch Welcome Kit KIT00145

GUDID 00853553005097

In Touch Blood Glucose Meter BG200, 1 In Touch Control Solution high/low, 3 boxes of In Touch Test Strips, 1 In Touch Lancing Device, 3 boxes of sterile In Touch Lancets, 1 Carrying Case, 1 Charger, 1 Charger cable, 1 Instructions for Use (English and Spanish), About Guide (English and Spanish)

LIVONGO HEALTH, INC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00853553005097
• NIH Device Record Key: e4fe7c8d-6a72-4064-afe9-9b82712f18b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In Touch Welcome Kit
• Version Model Number: In Touch
• Catalog Number: KIT00145
• 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

• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005097 [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: 2016-09-24

Devices Manufactured by LIVONGO HEALTH, INC

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• 00810079260058 - Teladoc Health, Inc: 2023-09-04 WM1500 Scale, BG95-M2
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• 00853553005738 - Livongo Test Strips - Mexico: 2022-09-28 OFG Livongo Test Strips BG300C - Mexico. 1 Vial of 50 Test Strips.
• 00853553005752 - Livongo WM1500 Welcome Kit: 2022-05-02 1 Weight Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
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• 00853553005073 - Livongo HT900 Welcome Kit: 2022-04-13 1 Livongo Blood Pressure Monitor HT900, 1 Livongo Blood Pressure Cuff, 1 Travel Case, 1 User Guide, 1 Quick Start Guide, 4 Durac