NIVO Nebulizer System

GUDID 05391517933437

NIVO Nebulizer, 5 Pack

AEROGEN LIMITED

Nebulizing system, non-heated
Primary Device ID05391517933437
NIH Device Record Key4afdb7b1-9a78-458a-950e-9c0b670ce52b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIVO Nebulizer System
Version Model Number1076302
Company DUNS989510003
Company NameAEROGEN LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com
Phone+35391540400
Emailinfo@aerogen.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391517933437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [NIVO Nebulizer System]

05391517933666NIVO Nebulizer
05391517933574NIVO Pro-X Controller Kit -JAPAN
05391517933567NIVO Pro-X Controller Kit-CANADA/TAIWAN
05391517933550NIVO Pro-X Controller Kit - INTL
05391517933543NIVO Pro-X Controller Kit-SCAND EU
05391517933536NIVO Pro-X Controller Kit- SOUTHERN EU
05391517933529NIVO Pro-X Controller Kit- NORTHERN EU
05391517933512NIVO Pro-X Controller Kit - ENG INTL
05391517933505NIVO Pro-X Controller Kit-AU/NZ
05391517933499NIVO Pro-X Controller Kit-UK/IE
05391517933482NIVO Pro-X Controller Kit - ENG EU
05391517933475NIVO Pro-X Controller Kit - Korea
05391517933468NIVO Pro-X Controller Kit - China
05391517933451NIVO Nebulizer 5 Pack - Korea
05391517933444NIVO Nebulizer 5 Pack - China
05391517933437NIVO Nebulizer, 5 Pack
05391517933420NIVO Pro-X Controller Kit - US

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