| Primary Device ID | 00606959061040 |
| NIH Device Record Key | 16779b37-615e-4757-8808-a322b7538c87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DreamStation Humidifier, INTL |
| Version Model Number | 00 |
| Catalog Number | INXH |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959061040 [Primary] |
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-01 |
| Device Publish Date | 2020-04-23 |
| 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 |