AEROGEN LIMITED

Address:M&M QUALTECH, PARKMORE,GALWAY,IE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Nebulizer (Direct Patient Interface) (CAF) (10)

Premarket Exempt

Clear

Aerogen® Solo; Aerogen Ultra - 05391517933826 Catalog Number :

Device Description : Aerogen Ultra Starter Kit with I-GuardTM Aerosol Mask (Adult) (US)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Solo; Aerogen Ultra - 05391517933840 Catalog Number :

Device Description : Aerogen Ultra Starter Kit with I-GuardTM Aerosol Mask (Pediatric) (US)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Solo Nebulizer System - 05391517933857 Catalog Number :

Device Description : Aerogen Solo Nebuliser

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Solo Nebulizer System - 05391517934021 Catalog Number :

Device Description : T-Piece Ped/Neo (PC)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen Solo Nebulizer System - 05391517934304 Catalog Number :

Device Description : Adult T-Piece (Trend)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen Solo Nebulizer System - 05391517934311 Catalog Number :

Device Description : Adult T-Piece Assembly

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen Solo Nebulizer System - 05391517935011 Catalog Number :

Device Description : Aerogen Solo Nebulizer Kit US

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® USB Controller System - 05391517935035 Catalog Number :

Device Description : Aerogen Solo USB Controller Starter Kit

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen Solo Nebulizer System - 05391517935561 Catalog Number :

Device Description : Aerogen Solo Nebulizer 5 Pack Assembly

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen Solo Nebulizer System - 05391517935578 Catalog Number :

Device Description : Aerogen Solo CNTS Kit

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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