| Primary Device ID | 00606959053984 |
| NIH Device Record Key | 100d2518-7bbb-494b-92e7-b3b2a43ca04b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Care Orchestrator Essence |
| Version Model Number | 2.1 |
| Catalog Number | 1135709 |
| Company DUNS | 080728314 |
| Company Name | Respironics, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(724)387-4000 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| RESPIRONICS.SERVICE@PHILIPS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959053984 [Primary] |
| NOU | CONTINUOUS, VENTILATOR, HOME USE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-21 |
| Device Publish Date | 2018-12-20 |
| 00606959053984 | Care Orchestrator Essence, Clinical data collection management information system application so |
| 30606959052834 | Care Orchestrator Essence, Clinical data collection management information system application so |
| 00606959062863 | Care Orchestrator Essence, Medical equipment clinical data interfacing software |