FDA.report

Rodney D. Mell

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96811543002842581Rodney D. Mell1N2020-04-251740 Golden Mile Highway Monroeville PA US 15146
30030015963003001596Rodney D. Mell1N2020-04-251740 Golden Mile Highway Monroeville PA US 15146

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381752065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
76692065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
381751294573549K991648REUSABLE CONTOUR II NASAL MASKBZD1999-05-28
381751053529754K982454BIPAP VISION VENTILATORY SUPPORTMNT1998-11-03
381752011311460K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
76691379158209K98007456 SERIES AEROSOL GENERATORCAF1998-06-12
381751736671402K963380CO 2 SMO PLUSBZC1997-01-22
76691765971878K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMBZH1996-10-25
76691270319922K962822OPTICHAMBERCAF1996-10-17
381751950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
76691950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
381751196356221K950397SYSTEM 22 VALVEBYE1995-04-14
76691529982471K940888SYSTEM 22 PAEDIATRIC MASKBYG1994-04-19
76691702899824K933889PERSONAL BEST LOW RANGEBZH1993-09-09
76691909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
381751909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
76691792530888K912866PEAK EXPIRATORY FLOW METERBZH1992-08-13
76691234966242K911807METERED DOSE INHALER (MDI) SPACERCAF1991-10-23
76691602657568K902292MODIFIED ASSESS(R) PEAK FLOW METERBZH1990-08-10
76691515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
381751515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
76692034426277K170853InnoSpire GoCAF2017-11-02
381751178595097K151120Simple T Pediatric Nasal MaskBZD2016-04-15
381751571900692K150639AF541 EE Full Face MaskBZD2015-09-18
381751961907368K142554Revolution Full Face MaskBZD2015-01-09
381751980527512K140980TI NASAL MASKBZD2015-02-10
381751776268550K140268SIMPLE T YOUTH NASAL MASKBZD2014-10-20
381751380443118K132168BRONCHOSCOPY ELBOWBZD2013-11-20
381751187907010K122847KANGAROO NASAL MASKBZD2013-03-06
381751811736981K121631SIMPLE T NASAL MASKBZD2012-10-05
381751485822823K120639PERFORMAX PEDIATRIC SE TOTAL FACE MASKCBK2012-07-10
381751593302298K120562PERFORMAX PEDIATRIC EE TOTAL FACE MASKBZD2012-07-17
381751740389246K110405TRUBLUE NASAL MASKBZD2011-06-06
381751899501073K110293OPTICHAMBER DIAMOND VALVED HOLDING CHAMBERNVP2011-08-09
76691899501073K110293OPTICHAMBER DIAMOND VALVED HOLDING CHAMBERNVP2011-08-09
381751241574365K103395PERFORMAX TOTAL FACE MASKBZD2011-03-24
76691418529283K102454I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEMCAF2011-10-25
381751834511539K101130BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASKMNS2010-09-02
381751443212431K101129ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASKCBK2010-09-16
76691159662292K100285LITETOUCH MASKCAF2010-06-29
381751159662292K100285LITETOUCH MASKCAF2010-06-29
381752035267530K092835COMFORTGEL NASAL MASKBZD2010-02-12
381751769485900K091843COMFORT TWIN NASAL MASKBZD2009-09-10
381751594016126K082866REVOLUTIONFULL FACE MASKBZD2009-01-30
381751022176079K082558COMFORTLITE NASAL MASKBZD2009-03-25
381751591025425K073600COMFORTGEL FULL FACE MASKBZD2008-04-25
76692056520549K072494AG-CLASSICCAF2008-02-12
76691698160926K072418OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBERCAF2007-09-12
76691263190416K063103AG-EDGE, MODEL 91200CAF2007-01-08
76691222031268K062689SIDESTREAM PLUSCAF2007-02-16
381751222031268K062689SIDESTREAM PLUSCAF2007-02-16
76691042080886K060404AG-PLUS, MODEL 91210CAF2006-06-22
76691474632528K052941I-NEB INSIGHT AAD SYSTEMCAF2005-12-09
381751066260950K043607BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEXBZD2005-01-28
76692059128678K042655INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456CAF2004-10-13
76691565300110K042483INVACARE PRO, COMPACT AND PORTABLE DESKTOPCAF2005-01-06
381752008438643K040595ALICE 5OLZ2004-03-18
76691040155602K032809HOSPITAL SPACERCAF2003-11-13
381751177357976K023135IMAGE3 SE DISPOSABLE FULL FACE MASKCBK2003-01-03
76691174065661K02144356 SERIES JET NEBULIZERCAF2002-10-21
381751346897568K002465SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876BZD2000-09-08
381751073210621
381751151791878
76691927075918
381751949371632
381751971828751

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
CAF222017-11-02
BZD192016-04-15
BZH41996-10-25
BWF41996-07-15
CBK32012-07-10
NVP22011-08-09
BYE21999-03-09
MNS12010-09-02
OLZ12004-03-18
MNT11998-11-03
BZC11997-01-22
BYG11994-04-19