Aerogen® USB Controller System

GUDID 05391517930542

Aerogen Solo USB Controller Starter Kit (US)

AEROGEN LIMITED

Nebulizing system, non-heated
Primary Device ID05391517930542
NIH Device Record Keyc837ab3a-edce-406e-beb8-a8956af3bc2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerogen® USB Controller System
Version Model NumberAG-UC1500-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 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 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 450 millibar and 1060 millibar
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391517930542 [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® USB Controller System]

05391517933369Aerogen USB Controller (US)
05391517932997Aerogen USB Controller Bundle
05391517932973Replacement Aerogen USB Controller, US
05391517931310Aerogen Pro USB Controller Starter Kit (US)
05391517930566Aerogen USB Controller (US)
05391517930542Aerogen Solo USB Controller Starter Kit (US)
05391517935035Aerogen Solo USB Controller Starter Kit

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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