| Primary Device ID | 00853553005325 |
| NIH Device Record Key | 18b677f7-0a06-4f21-bfdb-7a78fe5af904 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Livongo Refill Kit |
| Version Model Number | 200/200 |
| Catalog Number | KIT01209 |
| 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 | true |
| 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 |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853553005325 [Primary] |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-20 |
| Device Publish Date | 2018-08-20 |
| 00853553005325 | 4 bags/pieces Livongo Test Strips, 8 bags/pieces Livongo Sterile Lancets, 1 Instructions for Use |
| 00853553005264 | 6 bags Livongo Test Strips,4 bags Livongo Sterile Lancets, 1 Instructions for Use (English), 1 I |