| Primary Device ID | 00865536000234 |
| NIH Device Record Key | 7ec89e88-983e-469e-84eb-89c92ac08152 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeRO duet |
| Version Model Number | 3.1 |
| Company DUNS | 164972296 |
| Company Name | MEDICAL PREDICTIVE SCIENCE CORPORATION |
| 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 | true |
| 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 |
| Phone | 800-394-1625 |
| info@heroscore.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865536000234 [Primary] |
| DPS | Electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
| 00865536000210 - HeRO ES | 2018-07-06 |
| 00865536000227 - HeRO solo | 2018-07-06 A HeRO System for the private room |
| 00865536000234 - HeRO duet | 2018-07-06A standalone HeRO monitor for two infants |
| 00865536000234 - HeRO duet | 2018-07-06 A standalone HeRO monitor for two infants |
| 00865536000203 - HeRO symphony | 2018-03-29 Server based HeRO System |