| Primary Device ID | 20860004709507 |
| NIH Device Record Key | c6e5b6b6-617d-4c00-9c8e-020a99083c5f |
| 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 | 00860004709565 [Primary] |
| GS1 | 20860004709507 [Package] Contains: 00860004709565 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 | 2022-07-06 |
| Device Publish Date | 2022-06-28 |
| 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. |