| Primary Device ID | 00853553005387 |
| NIH Device Record Key | 371a300b-6e2c-4f0a-89a1-49e470d48cea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Livongo Blood Pressure Monitor |
| Version Model Number | UA-651BLE-LIV |
| Catalog Number | OFG01779 |
| 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 | true |
| 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 |
| Phone | 800.945.4355 |
| membersupport@livongo.com |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853553005387 [Primary] |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2018-09-14 |
| 00853553005387 | Digital Blood Pressure Monitor with Bluetooth connectivity |
| 00853553005042 | HT900 Device, Cellular Blood Pressure Monitor (4G) |