Aerogen® Solo Continuous Nebulization Tube Set

GUDID 05391517931181

Solo Continuous Nebulization Syringe (50 Pack)

AEROGEN LIMITED

Nebulizing system, non-heated
Primary Device ID05391517931181
NIH Device Record Key3e7a828d-9c12-4ddc-907e-2f0b0442fc59
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerogen® Solo Continuous Nebulization Tube Set
Version Model NumberAG-AS3095
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 Datetrue
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
GS105391517931181 [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 [Aerogen® Solo Continuous Nebulization Tube Set]

05391517933284Aerogen Solo Continuous Nebulization Syringe Set
05391517933260Aerogen Solo Continuous Nebulisation Tube Set
05391517931181Solo Continuous Nebulization Syringe (50 Pack)
05391517930412Tube Set for Use in Continuous Nebulization Only
0539151793040560ml Syringe for Use in Continuous Nebulization Only
05391517936216CNTS Syringe 5 Pack Assembly
05391517936209CNTS Syringe 5 Pack

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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