| Primary Device ID | 10860004709531 |
| NIH Device Record Key | a7934832-727d-4fd9-a221-c944782023a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pylo Health |
| Version Model Number | 802-LTE |
| Company DUNS | 116961530 |
| Company Name | PREVOUNCE HEALTH, LLC |
| 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 | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860004709534 [Primary] |
| GS1 | 10860004709531 [Package] Contains: 00860004709534 Package: Carton [10 Units] In Commercial Distribution |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-15 |
| Device Publish Date | 2021-06-07 |
| 00860004709503 | Cellular connected (Cat-M) non-invasive blood pressure monitor. |
| 10860004709517 | Cellular connected (LTE) body weight scale for remote patient monitoring. |
| 10860004709524 | Non-invasive digital blood pressure monitor. |
| 10860004709531 | Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor. |
| 20860004709507 | Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor. |
| 00860004709572 | Cellular connected (LTE) body weight scale for remote patient monitoring. |