Livongo Lancing Device OFG00405

GUDID 00853553005219

Lancing Device, Bag of 1

LIVONGO HEALTH, INC

Manual blood lancing device, reusable

• Primary Device ID: 00853553005219
• NIH Device Record Key: a15b8b25-c84a-4652-8dd6-26f8d2e2496b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livongo Lancing Device
• Version Model Number: Livongo
• Catalog Number: OFG00405
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853553005219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133584

FDA Product Code

• FMK: Lancet, Blood

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

• 00810079240142 - Livongo: 2025-10-03 BG300 control solution, MX
• 00810079260003 - Teladoc Health, Inc: 2023-09-04 WM1500, Modem Module FCC ID: XMR201707BG96
• 00810079260027 - Teladoc Health, Inc: 2023-09-04 SCALE, 4G CELLULAR WEIGHT MANAGEMENT, BRIDGE BRANDED, WM1500
• 00810079260058 - Teladoc Health, Inc: 2023-09-04 WM1500 Scale, BG95-M2
• 00853553005646 - Teladoc Health, Inc: 2023-09-04 KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries
• 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
• 00853553005042 - Livongo Blood Pressure Monitor: 2022-04-13 HT900 Device, Cellular Blood Pressure Monitor (4G)