| Primary Device ID | 00860011521211 |
| NIH Device Record Key | 83170bcf-8916-45ad-a9fa-a170e5b31581 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pylo Health |
| Version Model Number | GL1-CTR |
| Company DUNS | 116961530 |
| Company Name | Prevounce Health, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| 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 | 00860011521211 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
| 00860004709596 | Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor. |
| 00860011521259 | Blood Glucose Monitoring System Kit |
| 00860011521242 | Pylo single use lancets |
| 00860011521235 | Pylo Lancing Device |
| 00860011521228 | Pylo Blood Glucose Test Strip |
| 00860011521211 | Pylo Control Solution |
| 00860011521204 | Pylo Blood Glucose Meter Device GL1-LTE |
| 00860011521266 | LTE connected spot measurement pulse oximeter |