FDA.reportPublic FDA data

Janice Breen

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96127773001610754Janice Breen1N2026-01-01153 Industrial Blvd. PLATTSBURGH NY US 12901

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
402981123861465K992917AEROCHAMBER PLUS VALVED HOLDING CHAMBERCAF1999-09-14
402981206026635K900557MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBERCCQ1991-04-10
402981162318603K242667AeroChamber2go Anti-Static Valved Holding ChamberNVP2025-01-15
402981253762079K220145Monaghan medical filtered mouthpiece kitCAF2023-08-24
402981440605148K203400Corrugated tube with mouthpiece accessoryCAF2021-06-14
402982028225959K183108Combined Aerobika OPEP and VersaPAP deviceBWF2019-08-16
402981147554559K181649AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP2019-01-11
402981722942229K173918VersaPAP Positive Airway Pressure (PAP) DeviceBWF2018-08-17
402981206552055K173825MC 300R* NebulizerCAF2018-05-02
402981430041657K173367MC 300* NebulizerCAF2018-02-28
402981818528629K150173Aerobika OPEP Devive with ManometerBWF2015-10-15
402981125768269K140919RESPICONNECT ADAPTERCAF2014-08-15
402981306828032K131881OMBRA TABLE TOP COMPRESSORBTI2013-10-24
402981899085433K123614SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)CAF2013-03-11
402981328509564K123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICEBWF2013-05-16
402981446056654K112010AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)NVP2012-07-11
402981712314580K110136RESPICHAMBER VALVED HOLDING CHAMBERNVP2011-04-18
402981291514569K090065AEROCHAMBER MINI VENTILATION CHAMBERCAF2009-04-09
402981260971437K080926AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZERCAF2008-08-12
402981112489800K070674AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATORNVP2007-04-11
402981466499079K053605AEROECLIPSE II BREATH ACTUATED NEBULIZERCAF2006-02-27
402981139648558K052332AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBERNVP2005-09-21
402981211454245K032972AEROCHAMBER MAX VALVED HOLDING CHAMBERCAF2004-01-14
402981466545217K031514MODIFICATION TO TRUPEAK PEAK FLOW METERBZH2003-05-23
402981781278871K001137AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)CAF2000-07-05
402981226533233
402981454255637
402981400644136

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF122023-08-24
NVP82025-01-15
BWF42019-08-16
BTI12013-10-24
BZH12003-05-23
CCQ11991-04-10