| Primary Device ID | 00850014861056 |
| NIH Device Record Key | 887fcdf4-4416-4156-a9f7-6153fbd111bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartsCare C1 Plus Multi-Functional Monitoring System |
| Version Model Number | TD-4289 |
| Company DUNS | 085509873 |
| Company Name | Hearts Bio, Inc. |
| 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 | 00850014861056 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-08 |
| Device Publish Date | 2025-03-31 |
| 00850014861056 - HeartsCare C1 Plus Multi-Functional Monitoring System | 2025-04-08 |
| 00850014861056 - HeartsCare C1 Plus Multi-Functional Monitoring System | 2025-04-08 |
| 00850014861629 - HeartsCare BLOOD GLUCOSE TEST STRIPS (50PCS/BOX) | 2025-04-08 |
| 00850014861407 - HeartsCare LACTATE TEST STRIPS (10PCS/BOX) | 2024-07-16 |
| 00850014861537 - HeartsCare LACTATE TEST STRIPS (25PCS/BOX) | 2024-07-16 |
| 00850014861353 - HeartsCare C1 URIC ACID TEST STRIPS(10PCS/BOX) | 2023-08-16 |
| 00850014861360 - HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) | 2023-08-16 |
| 00850014861049 - HeartsCare C1 multi-functional monitoring system | 2022-02-03 |