| Primary Device ID | 00850893007033 |
| NIH Device Record Key | f8407987-eb17-4d84-b68d-bccaf12c35ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AWARE DART iOS Client |
| Version Model Number | 1.0 |
| Company DUNS | 080221585 |
| Company Name | AMBIENT CLINICAL ANALYTICS, 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850893007033 [Primary] |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-09-03 |
| 00850893007002 - AWARE | 2018-11-22 |
| 00850893007019 - AWARE | 2018-11-22 Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA p |
| 00850893007026 - AWARE DART | 2018-11-22 Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical set |
| 00850893007033 - AWARE DART iOS Client | 2018-11-22Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client. |
| 00850893007033 - AWARE DART iOS Client | 2018-11-22 Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS |