Aerogen® Professional Nebulizer System

GUDID 05391517930030

Pro Adult T-Piece 22mm

AEROGEN LIMITED

Nebulizing system, non-heated
Primary Device ID05391517930030
NIH Device Record Key3dc5f4bf-cf22-40e5-8be2-d7d2b047f2e5
Commercial Distribution Discontinuation2018-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAerogen® Professional Nebulizer System
Version Model NumberAG-AP1010
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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling 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
Handling Environment Atmospheric PressureBetween 450 millibar and 1100 millibar
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391517930030 [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 Number5
Public Version Date2018-09-24
Device Publish Date2016-09-16

On-Brand Devices [Aerogen® Professional Nebulizer System]

05391517933727Aerogen Pro Connector
05391517933710Pro Pediatric T Piece 15 mm & Adapter Kit
05391517933376Aerogen Pro T-Piece
05391517933154Aerogen Pro Elbow Facemask 22m/22f
05391517933147Aerogen Pro Elbow Facemask
05391517933130Aerogen Pro Vented Elbow
05391517933116Aerogen Pro Control Module Assembly (US)
05391517933109Aerogen Pro 10mm T-Piece Neonate (PS) (P/N 10-203) and Plug (P/N 10-040) Assembly
05391517933093T-Piece neonate (P/N 10-123) and Plug (P/N 10-040) Assembly
05391517933079Aerogen Pro Connector
05391517933062T-Piece, Ped/ Neo (Polysulphone) (Annealed) (P/N 10-057) and Plug (P/N 10-040) Assembly
05391517933055Aerogen Pro T-Piece Plug Assembly
05391517933024Aerogen Pro Nebulizer
05391517931938Pro Pediatric T-Piece 10mm
05391517931488Aerogen Pro Controller (US)
05391517931341Aerogen Pro Control Module (US)
05391517931297Aerogen Pro Mask Kit (US)
05391517930740Pro Nebulizer
05391517930177Pro Nebulizer & T-Piece
05391517930160Pro Nebulizer & Pediatric T-Piece
05391517930108Aerogen Pro Vented Elbow
05391517930085Pro Pediatric T-Piece 12mm
05391517930061Pro Pediatric Adapter Kit
05391517930047Pro Pediatric T-Piece 15mm
05391517930030Pro Adult T-Piece 22mm
05391517930016Aerogen Pro Nebulizer System

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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