| Primary Device ID | 00853553005271 |
| NIH Device Record Key | c52d17f5-9c4e-49d4-b6d7-5d7ed5def639 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Livongo Demo Kit |
| Version Model Number | Livongo |
| Catalog Number | KIT00425 |
| 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 |
| Phone | 800.945.4355 |
| membersupport@livongo.com |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 75 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 75 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 75 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853553005271 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 00853553005318 | BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 box of Livongo Contro |
| 00853553005271 | Livongo Demo Kit with BG300, 1 vial of Livongo Test strips, 1 bag of Livongo Sterile Lancets, 1 |