AEROGEN LIMITED

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

No

Clear

Aerogen® Professional Nebulizer System - 05391517930016 Catalog Number :

Device Description : Aerogen Pro Nebulizer System

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930030 Catalog Number :

Device Description : Pro Adult T-Piece 22mm

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930047 Catalog Number :

Device Description : Pro Pediatric T-Piece 15mm

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930061 Catalog Number :

Device Description : Pro Pediatric Adapter Kit

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930085 Catalog Number :

Device Description : Pro Pediatric T-Piece 12mm

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930108 Catalog Number :

Device Description : Aerogen Pro Vented Elbow

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930160 Catalog Number :

Device Description : Pro Nebulizer & Pediatric T-Piece

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Professional Nebulizer System - 05391517930177 Catalog Number :

Device Description : Pro Nebulizer & T-Piece

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Solo Nebulizer System - 05391517930221 Catalog Number :

Device Description : Aerogen Solo Starter Kit (US)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aerogen® Solo Nebulizer System - 05391517930238 Catalog Number :

Device Description : Solo Nebuliser (5 Pack)

Device Class : 2

Duns Number: 989510003

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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