| Primary Device ID | 00810079260003 |
| NIH Device Record Key | c671756a-c844-4b5d-9b98-d146129bc298 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teladoc Health, Inc |
| Version Model Number | WM1500 Modem Module |
| Catalog Number | OFG06308 |
| Company DUNS | 829984561 |
| Company Name | LIVONGO HEALTH, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | 800.945.4355 |
| membersupport@livongo.com | |
| Phone | 800.945.4355 |
| membersupport@livongo.com |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810079260003 [Primary] |
| FRI | Scale, Stand-On, Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00853553005646 | KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries |
| 00810079260058 | WM1500 Scale, BG95-M2 |
| 00810079260027 | SCALE, 4G CELLULAR WEIGHT MANAGEMENT, BRIDGE BRANDED, WM1500 |
| 00810079260003 | WM1500, Modem Module FCC ID: XMR201707BG96 |