Aerogen® Solo Nebulization System

GUDID 05391517930627

Aerogen Pro-X Controller Kit (US)

AEROGEN LIMITED

Nebulizing system, non-heated
Primary Device ID05391517930627
NIH Device Record Keyd9c39ed2-2fcb-4a93-a19c-a80295c956ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerogen® Solo Nebulization System
Version Model NumberAG-PX1000-US
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 Usefalse
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
GS105391517930627 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Aerogen® Solo Nebulization System]

05391517931648Aerogen Pro-X Controller (US)
05391517930627Aerogen Pro-X Controller Kit (US)

Trademark Results [Aerogen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AEROGEN
AEROGEN
85401215 not registered Dead/Abandoned
Adams Golf IP, Ltd.
2011-08-18
AEROGEN
AEROGEN
76232170 not registered Dead/Abandoned
AeroGen, Inc.
2001-03-28
AEROGEN
AEROGEN
76204914 not registered Dead/Abandoned
ByData, Inc.
2001-02-05
AEROGEN
AEROGEN
76204913 2595836 Dead/Cancelled
ByData, Inc.
2001-02-05
AEROGEN
AEROGEN
75221960 2459921 Live/Registered
STAMFORD DEVICES LIMITED
1997-01-02
AEROGEN
AEROGEN
74130036 1737464 Dead/Cancelled
ROBERT J. MATTHEWS CO.
1991-01-14
AEROGEN
AEROGEN
72291620 0876826 Dead/Expired
MADISON CHEMICAL CORPORATION
1968-02-21
AEROGEN
AEROGEN
72291620 0876826 Dead/Expired
SYSTEMS GENERAL, INC.
1968-02-21

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