Aerogen® Solo; Aerogen Ultra

GUDID 05391517936322

Ultra & Filter Assembly

AEROGEN LIMITED

Benchtop nebulizer, non-heated
Primary Device ID05391517936322
NIH Device Record Key82f10ed6-5f1f-400e-9f64-38d3c76d9b96
Commercial Distribution StatusIn Commercial Distribution
Brand NameAerogen® Solo; Aerogen Ultra
Version Model Number90-213
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105391517936322 [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 Number2
Public Version Date2022-06-10
Device Publish Date2022-04-11

On-Brand Devices [Aerogen® Solo; Aerogen Ultra]

05391517933840Aerogen Ultra Starter Kit with I-GuardTM Aerosol Mask (Pediatric) (US)
05391517933826Aerogen Ultra Starter Kit with I-GuardTM Aerosol Mask (Adult) (US)
05391517933802Aerogen Ultra Kit with I-GuardTM Aerosol Mask (Pediatric) (US)
05391517933789Aerogen Ultra Kit with I-GuardTM Aerosol Mask (Adult) (US)
05391517933697Off-Vent Accessory Nebulizer
05391517933338Aerogen Ultra Assembly
05391517933321Oxygen Tubing 2m
05391517932355Aerogen Ultra Bundle
05391517930702Aerogen Ultra Starter Kit
05391517930580Aerogen Ultra
05391517935776Ultra Assembly
05391517935769Ultra Nebulizer Assembly
05391517936292Ultra Nebulizer Assembly (Top Seal)
05391517936339Aerogen Ultra with Filter
05391517936322Ultra & Filter Assembly
05391517936315Aerogen Ultra Starter Kit with Filter
05391517936308Ultra Solo & Filter Assembly
05391517936896Aerogen Ultra Mouthpiece (bagged)
05391517936797Ultra Mouthpiece (10 Pack) (US)
05391517936780Aerogen Oxygen Tubing (10 Pack) (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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.