| Primary Device ID | 00843511100711 |
| NIH Device Record Key | f34ca9ed-1d2e-41e9-ba5d-e777da5ceef6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cura Bluetooth Blood Pressure Monitor |
| Version Model Number | LS810-B |
| Catalog Number | LS810-B |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, 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 | true |
| Serial Number | false |
| 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 |
| Phone | 3044134851 |
| customerservice@omniamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511100711 [Primary] |
| 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 | 2020-03-06 |
| Device Publish Date | 2020-02-27 |
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| 00843511128258 - Omnia Medical Instruments | 2025-07-23 |
| 00843511128265 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S Inserter, for 10, 12, 14mm heights |
| 00843511128272 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S-Inserter for 16 and 18 heights |
| 00843511128296 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 10mm and 12mm heights |
| 00843511128302 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 14mm and 16mm heights |
| 00843511128319 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 18mm heights |
| 00843511128326 - TiBrid-SA | 2025-07-23 TiBrid-SA Tack Inserter Driver |