Primary Device ID | 05391517933420 |
NIH Device Record Key | 1db6fd61-d6af-4fd9-81bb-340f113e7447 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NIVO Nebulizer System |
Version Model Number | 1076301 |
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 | 05391517933420 [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 |