| Primary Device ID | 00606959049963 |
| NIH Device Record Key | ecc58910-5d97-40b5-981d-027de4ebfdce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DreamMapper iOS China Instance v 2.11 |
| Version Model Number | 2.11 |
| Catalog Number | 1136968 |
| 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(999)999-9999 |
| xx@xx.xx | |
| Phone | +1(999)999-9999 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959049963 [Primary] |
| MNS | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2019-04-20 |
| 00606959051942 - Trilogy Evo | 2022-05-23 Trilogy Evo, USA |
| 00606959417540 - DreamStation | 2022-01-10 Micro-Flexible Heated 12mm Tube |
| 00606959060135 - Therapy Mask 3100 | 2021-12-16 Medium Wide, Therapy Mask 3100 Silicone |
| 00606959060098 - Therapy Mask 3100 | 2021-11-04 |
| 00606959060104 - Therapy Mask 3100 | 2021-11-04 |
| 00606959060128 - Therapy Mask 3100 | 2021-11-04 |
| 00606959063082 - DreamStation 2 | 2021-11-04 |
| 00606959063228 - DreamStation 2 | 2021-11-04 |