| Primary Device ID | 05391517933475 |
| NIH Device Record Key | 1006ac4b-631c-4c19-b643-56daa860584e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIVO Nebulizer System |
| Version Model Number | 1117345 |
| Company DUNS | 989510003 |
| Company Name | AEROGEN LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| 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 Atmospheric Pressure | Between 450 millibar and 1100 millibar |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391517933475 [Primary] |
| CAF | Nebulizer (Direct Patient Interface) |
| 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 | 2016-09-16 |
| 05391517933666 | NIVO Nebulizer |
| 05391517933574 | NIVO Pro-X Controller Kit -JAPAN |
| 05391517933567 | NIVO Pro-X Controller Kit-CANADA/TAIWAN |
| 05391517933550 | NIVO Pro-X Controller Kit - INTL |
| 05391517933543 | NIVO Pro-X Controller Kit-SCAND EU |
| 05391517933536 | NIVO Pro-X Controller Kit- SOUTHERN EU |
| 05391517933529 | NIVO Pro-X Controller Kit- NORTHERN EU |
| 05391517933512 | NIVO Pro-X Controller Kit - ENG INTL |
| 05391517933505 | NIVO Pro-X Controller Kit-AU/NZ |
| 05391517933499 | NIVO Pro-X Controller Kit-UK/IE |
| 05391517933482 | NIVO Pro-X Controller Kit - ENG EU |
| 05391517933475 | NIVO Pro-X Controller Kit - Korea |
| 05391517933468 | NIVO Pro-X Controller Kit - China |
| 05391517933451 | NIVO Nebulizer 5 Pack - Korea |
| 05391517933444 | NIVO Nebulizer 5 Pack - China |
| 05391517933437 | NIVO Nebulizer, 5 Pack |
| 05391517933420 | NIVO Pro-X Controller Kit - US |