Livongo OFG000002
GUDID 00810079240142
BG300 control solution, MX
LIVONGO HEALTH, INC
Glucose IVD, control| Primary Device ID | 00810079240142 |
| NIH Device Record Key | cf106c7e-896b-45c5-9157-7dba8f884e23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Livongo |
| Version Model Number | BG300 - MX |
| Catalog Number | OFG000002 |
| 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 | 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 | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com | |
| Phone | 1-800-945-4355 |
| rc_team@teladochealth.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810079240142 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133584
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
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 | 2025-10-03 |
| Device Publish Date | 2025-09-25 |
Devices Manufactured by LIVONGO HEALTH, INC
| 00810079240142 - Livongo | 2025-10-03BG300 control solution, MX |
| 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) |
Trademark Results [Livongo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIVONGO 86390862 5023121 Live/Registered |
Livongo Health, Inc. 2014-09-10 |
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