| 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 |
| 00843511112905 - Omnia Medical Instruments | 2025-02-11 CURETTE, RIGHT RECTANGLE |
| 00843511112912 - Omnia Medical Instruments | 2025-02-11 CURETTE, LEFT RECTANGLE |
| 00843511112929 - Omnia Medical Instruments | 2025-02-11 CURETTE, CIRCLE |
| 00843511112936 - Omnia Medical Instruments | 2025-02-11 CURETTE, ANGLED CIRCLE |
| 00843511113148 - TiBrid-SA | 2025-02-11 Extended Tip Awl |
| 00843511122164 - Omnia Medical Instruments | 2025-02-11 TS-TO HANDLE |
| 00843511128197 - Omnia Medical Disc Prep Instruments | 2025-02-05 Boot Spacer, 12mm |
| 00843511128203 - Omnia Medical Disc Prep Instruments | 2025-02-05 Boot Spacer, 14mm |