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Aerogen, Inc.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: —
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EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (138)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Aerogen® Solo Nebulizer System	60-045	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS3300-US	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS5000-PH	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS3035	FDA UDI	Class II	Active
Aerogen® Solo; Aerogen Ultra	90-214	FDA UDI	Class II	Active
NIVO Nebulizer System	1098093	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	99-253	FDA UDI	Class II	Unknown
Aerogen® USB Controller System	AG-UC7700-US	FDA UDI	Class II	Active
Aerogen® Professional Nebulizer System	AG-AP1500-US	FDA UDI	Class II	Unknown
Aerogen® Solo; Aerogen Ultra	AG-AS7501-US	FDA UDI	Class II	Active
Aerogen® Solo; Aerogen Ultra	AG-AS7700-US	FDA UDI	Class II	Active
NIVO Nebulizer System	1079422	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS3350-US	FDA UDI	Class II	Active
Aerogen® Professional Nebulizer System	60-044	FDA UDI	Class II	Active
Aerogen® Professional Nebulizer System	AG-AP1035	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulization System	AG-PX1000-US	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS3300-US	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3001	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3500-US	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS4300-US	FDA UDI	Class II	Unknown
Aerogen Solo Nebulizer System	AG-AS3010-US	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3600-US	FDA UDI	Class II	Unknown
Aerogen® USB Controller System	AG-UC1600-US	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	90-039	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3300	FDA UDI	Class II	Unknown
Aerogen® Solo; Aerogen Ultra	90-252	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3200-US	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	AG-AS3036	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	90-211	FDA UDI	Class II	Unknown
Aerogen® USB Controller System	AG-UC1000-US	FDA UDI	Class II	Unknown
Aerogen® Solo; Aerogen Ultra	90-213	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	10-052	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	10-047	FDA UDI	Class II	Active
Aerogen® USB Controller System	AG-UC2000-US	FDA UDI	Class II	Unknown
NIVO Nebulizer System	1082694	FDA UDI	Class II	Unknown
Aerogen® USB Controller System	80-014	FDA UDI	Class II	Active
NIVO Nebulizer System	1079421	FDA UDI	Class II	Unknown
Aerogen® Solo Continuous Nebulization Tube Set	AG-AS3089-US	FDA UDI	Class II	Active
Aerogen® Solo; Aerogen Ultra	90-205	FDA UDI	Class II	Active
Aerogen® USB Controller System	AG-UC1500-US	FDA UDI	Class II	Active
NIVO Nebulizer System	1082695	FDA UDI	Class II	Unknown
Aerogen® USB Controller System	AG-UC1000-US	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	10-204	FDA UDI	Class II	Active
Aerogen® Solo Nebulizer System	10-355	FDA UDI	Class II	Active
Aerogen® Solo; Aerogen Ultra	90-212	FDA UDI	Class II	Active
NIVO Nebulizer System	90-067	FDA UDI	Class II	Unknown
Aerogen® Solo; Aerogen Ultra	AG-AS7009-US	FDA UDI	Class II	Active
Aerogen® Professional Nebulizer System	AG-AP6000-US	FDA UDI	Class II	Unknown
Aerogen® Professional Nebulizer System	AG-AP1065	FDA UDI	Class II	Unknown
Aerogen® Solo Nebulizer System	AG-AS3020	FDA UDI	Class II	Active

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