FDA.reportPublic FDA data

Aerogen® Solo; Aerogen Ultra

Primary DI
05391517935769
Brand
Aerogen® Solo; Aerogen Ultra
Company
AEROGEN LIMITED
Model
90-205
Device description
Ultra Nebulizer Assembly
Published
2020-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133360000AERONEB SOLO; AERONEB SOLO ADAPTERAerogen, Ltd.2014-10-17CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391517935769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391517935769053915179357695391517935769

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure450 millibar1100 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35391540400info@aerogen.com

Regulatory Flags#

DUNS number
989510003
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391517937442Aerogen® Solo Nebulizer SystemAG-AS33002025-08-11
05391517936353Aerogen® Solo Nebulizer SystemAG-AS30012025-06-20
05391517938043Aerogen® Solo Nebulizer SystemAG-AS3350-US2025-06-20
05391517938050Aerogen® Solo Nebulizer SystemAG-AS3300-US2025-06-20
05391517938067Aerogen® Solo Nebulizer SystemAG-AS3100-US2025-06-20
05391517938074Aerogen® Solo Nebulizer SystemAG-AS3200-US2025-06-20
05391517938142Aerogen® Solo; Aerogen UltraAG-AS7700-US2025-04-22
05391517937466Aerogen® Solo Nebulizer SystemAG-AS3300-US2024-10-28
05391517935561Aerogen Solo Nebulizer System90-2042020-05-19
05391517935578Aerogen Solo Nebulizer SystemAG-AS3080-US2020-05-19
05391517936308Aerogen® Solo; Aerogen Ultra90-2122022-04-11
05391517936315Aerogen® Solo; Aerogen UltraAG-AS7509-US2022-04-11
05391517936292Aerogen® Solo; Aerogen Ultra90-2142021-09-10
05391517935035Aerogen® USB Controller SystemAG-UC2500-US2020-03-09
05391517930399Aerogen® Solo Nebulizer SystemAG-AS35002016-09-16
05391517930542Aerogen® USB Controller SystemAG-UC1500-US2016-09-16
05391517930702Aerogen® Solo; Aerogen UltraAG-AS7500-US2016-09-16
05391517932355Aerogen® Solo; Aerogen UltraAG-AS7700-US2016-09-16
05391517932515Aerogen® Solo Nebulizer SystemAG-AS3200-US2016-09-16
05391517932522Aerogen® Solo Nebulizer SystemAG-AS3500-US2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02