Rodney D Mell

FDA Filings

This page includes the latest FDA filings for Rodney D Mell. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9681154
• FEI Number: 3002842581
• Name: Rodney D. Mell
• Owner & Operator: Philips Medical Systems International BV
• Contact Address: Tussendiepen 4 ; Drachten NL-NOTA 9206 AD NL
• US Agent:
  • Rodney D. Mell
  • 724 3877474
  • rod.mell@philips.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1740 Golden Mile Highway ; Monroeville, PA 15146 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3003001596
• FEI Number: 3003001596
• Name: Rodney D. Mell
• Owner & Operator: Philips Medical Systems International BV
• Contact Address: Tussendiepen 4 ; Drachten NL-NOTA 9206 AD NL
• US Agent:
  • Rodney D. Mell
  • 724 3877474
  • rod.mell@philips.com
• Importing Logistics Registration:
  • Importer: DHL Express
  • Address: 1210 Pine Island Rd ; Plantation, FL 33324 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Expeditors International of Washington Inc
  • Address: 1015 Third Ave 12th Floor ; Seattle, WA 98104 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: FedEx Corporation
  • Address: 942 South Shady Grove Road ; Memphis, TN 38120 UNITED STATES
• Importing Logistics Registration:
  • Importer: Panalpina
  • Address: 67 Park Place ; Morristown, NJ 07960 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: UPS Supply Chain Solutions
  • Address: 12380 Morris Road ; Alpharetta, GA 30005 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1740 Golden Mile Highway ; Monroeville, PA 15146 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K132168 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Bronchoscopy Elbow	2018-08-07
PMN K170853 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Innospire Go	2017-11-14
PMN K150639 | BZD Rodney D. Mell [Philips Medical Systems International BV]	AF541 EE Full Face Mask	2017-09-13
PMN K940888 | BYG Rodney D. Mell [Philips Medical Systems International BV]	SIDESTREAM TUCKER THE TURTLE MASK, SYSTEM 22 PAEDIATRIC MASK	2017-06-19
PMN K151120 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Wisp Pediatric Nasal Mask	2016-05-23
PMN K151120 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Wisp Pediatric Nasal Mask SE Elbow Accessory	2016-05-23
PMN K151120 | BZD Rodney D. Mell [Philips Medical Systems International BV]	PN841 SE Nasal Mask	2016-05-23
PMN K151120 | BZD Rodney D. Mell [Philips Medical Systems International BV]	PN841 Nasal Mask	2016-05-23
PMN K142554 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Shimmer Full Face Mask	2015-11-09
PMN K142554 | BZD Rodney D. Mell [Philips Medical Systems International BV]	S/M/L/MW Dreamwear Full Med Frm w/HGR	2015-11-09
PMN K140268 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Wisp Youth Nasal Mask	2015-06-17
PMN K140980 | BZD Rodney D. Mell [Philips Medical Systems International BV]	DreamWisp Nasal Mask (RIMR/RISZ/RIMP)	2015-03-06
PMN K140980 | BZD Rodney D. Mell [Philips Medical Systems International BV]	DreamWear Nasal Mask (RIMR/RISZ/Volcano)	2015-03-06
PMN K140980 | BZD Rodney D. Mell [Philips Medical Systems International BV]	DreamWear Gel Pillows Mask (RIMR/RISZ)	2015-03-06
PMN K140980 | BZD Rodney D. Mell [Philips Medical Systems International BV]	DreamWear Full Mask (RIMR/RISZ/Volcano)	2015-03-06
PMN K122847 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Nuance Nasal Pillow Mask	2013-04-26
PMN K121631 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Wisp SE Nasal Mask (RIMR, RISZ)	2012-11-07
PMN K121631 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Wisp Nasal Mask (RIMR, RISZ, Volcano)	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Reusable Neonatal CO2 Airway Adapter	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Reusable Airway Adapter MaInstream CO2 Adult	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Pediatric/Adult Airway Adapter	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Pediatric/Adult Airway Adapter with Mouthpiece	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Neonatal/Pediatric Airway Adapter	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Neonatal Airway Adapter	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	NOVA DISP AIRW ADPTRADLT 20/C	2012-11-07
BZA Rodney D. Mell [Philips Medical Systems International BV]	Infant Airway Adapter, Disposable	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Standard Size NICO Sensor	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Small Size NICO Sensor	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Pediatric/Adult Flow Sensor Series 3	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Pediatric Combined CO2/Flow Sensor Series 3	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Pediatric / Adult Combined CO2/Flow Sensor Series 3	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Neonatal Flow Sensor Series 3	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Neonatal Combined CO2/Flow Sensor Series 3	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	Large Size NICO Sensor	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	CO2/Flow Sensor Pediatric	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	CO2/Flow Sensor Neonatal	2012-11-07
BXP Rodney D. Mell [Philips Medical Systems International BV]	CO2/Flow Sensor Adult	2012-11-07
PMN K120639 | CBK Rodney D. Mell [Philips Medical Systems International BV]	Performax Pediatric SE Total FFM	2012-08-14
PMN K120562 | BZD Rodney D. Mell [Philips Medical Systems International BV]	PerforMax Pediatric EE Total FFM - Leak 1 and 2	2012-08-14
PMN K102454 | CAF Rodney D. Mell [Philips Medical Systems International BV]	I-neb TIM/General Purpose	2011-11-17
PMN K110293 | NVP Rodney D. Mell [Philips Medical Systems International BV]	OptiChamber Diamond with Lite Touch mask	2011-09-15
PMN K110293 | NVP Rodney D. Mell [Philips Medical Systems International BV]	OptiChamber Diamond with Lite Touch mask	2011-09-15
PMN K072418 | CAF Rodney D. Mell [Philips Medical Systems International BV]	OptiChamber Advantage Anti-Static Valved Holding Chamber	2011-08-02
PMN K110405 | BZD Rodney D. Mell [Philips Medical Systems International BV]	TrueBlue Nasal Mask	2011-06-10
PMN K110405 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Pico SE Nasal Mask	2011-06-10
PMN K103395 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Bronchoscopy elbow	2011-04-12
PMN K103395 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Bronchoscopy Elbow, Click Style	2011-04-12
PMN K101130 | MNS Rodney D. Mell [Philips Medical Systems International BV]	AF541 FFM	2010-10-14
PMN K101130 | MNS Rodney D. Mell [Philips Medical Systems International BV]	AF531 FFM	2010-10-14
PMN K101130 | MNS Rodney D. Mell [Philips Medical Systems International BV]	AF421 FFM	2010-10-14
PMN K101129 | CBK Rodney D. Mell [Philips Medical Systems International BV]	AF541 SE FFM	2010-10-14
PMN K101129 | CBK Rodney D. Mell [Philips Medical Systems International BV]	AF531 SE FFM	2010-10-14
PMN K101129 | CBK Rodney D. Mell [Philips Medical Systems International BV]	AF421 SE FFM	2010-10-14
PMN K082866 | BZD Rodney D. Mell [Philips Medical Systems International BV]	ComfortFull FFM - RSZ	2010-08-03
PMN K082866 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Amara View FFM - RIMR	2010-08-03
PMN K082866 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Amara FFM - RIMR	2010-08-03
PMN K082558 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Optilife Nasal Mask	2010-08-03
PMN K082558 | BZD Rodney D. Mell [Philips Medical Systems International BV]	AP111 Nasal Mask	2010-08-03
PMN K073600 | BZD Rodney D. Mell [Philips Medical Systems International BV]	ComfortGel Blue FFM	2010-08-03
PMN K073600 | BZD Rodney D. Mell [Philips Medical Systems International BV]	AF811 FFM	2010-08-03
PMN K092835 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Comfort Gel Blue Nasal Mask	2010-08-02
PMN K091843 | BZD Rodney D. Mell [Philips Medical Systems International BV]	EasyLife Nasal Mask	2010-08-02
PMN K100285 | CAF Rodney D. Mell [Philips Medical Systems International BV]	LiteTouch Mask	2010-07-14
PMN K100285 | CAF Rodney D. Mell [Philips Medical Systems International BV]	LiteTouch Mask	2010-07-14
CAT Rodney D. Mell [Philips Medical Systems International BV]	Nasal Cannula	2009-06-16
CAT Rodney D. Mell [Philips Medical Systems International BV]	AC611 High Flow Nasal Cannula	2009-06-16
PMN K980074 | CAF Rodney D. Mell [Philips Medical Systems International BV]	OptiNeb Pro	2009-02-19
PMN K072494 | CAF Rodney D. Mell [Philips Medical Systems International BV]	AG Classic Nebulizer	2009-02-19
PMN K063103 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Micro Elite Nebulizer	2009-02-19
PMN K063103 | CAF Rodney D. Mell [Philips Medical Systems International BV]	AG Edge Nebulizer	2009-02-19
PMN K060404 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Innospire Mini	2009-02-19
PMN K042483 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Stratos Pro Nebulizer	2009-02-19
PMN K042483 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Stratos Portable Nebulizer	2009-02-19
PMN K042483 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Stratos Compact Nebulizer	2009-02-19
PMN K021443 | CAF Rodney D. Mell [Philips Medical Systems International BV]	OptiNeb Pro Nebulizer	2009-02-19
PMN K021443 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Medel Jet Nebulizer	2009-02-19
PMN K991648 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Contour Deluxe/Comfort/Ptrak Nasal Mask	2007-12-31
PMN K991648 | BZD Rodney D. Mell [Philips Medical Systems International BV]	AP111 EE/SE Nasal Mask	2007-12-31
PMN K982454 | MNT Rodney D. Mell [Philips Medical Systems International BV]	Disposable/FEP/Invasive Circuits	2007-12-31
PMN K982454 | MNT Rodney D. Mell [Philips Medical Systems International BV]	BiPAP Vision	2007-12-31
PMN K043607 | BZD Rodney D. Mell [Philips Medical Systems International BV]	Or Components	2007-12-31
PMN K043607 | BZD Rodney D. Mell [Philips Medical Systems International BV]	BiPAP Pro 2 & Heated Humidifier	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	Sleepware	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	Sleepware G3	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	LDxS	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	LDxN	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	LDx	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	ECG wireset	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	Alice PSG or components	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	Alice 6 PSG Base Station LDE	2007-12-31
PMN K040595 | OLZ Rodney D. Mell [Philips Medical Systems International BV]	Alice 6 Headbox LDE	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	Sleepware	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	Sleepware G3	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	LDxS	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	LDxN	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	LDx	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	ECG wireset	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	Alice PSG or components	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	Alice 6 PSG Base Station LDE	2007-12-31
PMN K040595 | OLV Rodney D. Mell [Philips Medical Systems International BV]	Alice 6 Headbox LDE	2007-12-31
PMN K002465 | BZD Rodney D. Mell [Philips Medical Systems International BV]	PTrak FFM	2007-12-31
PMN K002465 | BZD Rodney D. Mell [Philips Medical Systems International BV]	FFM	2007-12-31
PMN K963380 | BZC Rodney D. Mell [Philips Medical Systems International BV]	Flow Sensor	2007-12-18
PMN K963380 | BZC Rodney D. Mell [Philips Medical Systems International BV]	FloTrak CO2 Sensor	2007-12-18
PMN K962924 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Peak Flow Meter	2007-12-07
PMN K962924 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Asthma Mentor	2007-12-07
PMN K962924 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Asthma Check	2007-12-07
PMN K962822 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Opti Chamber Valved Holding Chamber	2007-12-07
PMN K961077 | BWF Rodney D. Mell [Philips Medical Systems International BV]	Threshold Pep	2007-12-07
PMN K961077 | BWF Rodney D. Mell [Philips Medical Systems International BV]	Threshold Pep	2007-12-07
PMN K933889 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Personal Best Low Range Peak Flow Meter	2007-12-07
PMN K912866 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Personal Best Full Range Peak Flow Meter	2007-12-07
PMN K912866 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Meter, Peak Flow, Spirometry ? Personal Best EU Peak Flow Meter	2007-12-07
PMN K911807 | CAF Rodney D. Mell [Philips Medical Systems International BV]	OptiHaler Drug Delivery System	2007-12-07
PMN K902292 | BZH Rodney D. Mell [Philips Medical Systems International BV]	Assess Low Range Peak Flow Meter	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Pediatric Mask	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Pediatric Mask	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Nebulizer	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Nebulizer	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Adult Mask	2007-12-07
PMN K062689 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Plus Adult Mask	2007-12-07
PMN K042655 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Innospire Essence	2007-12-07
PMN K042655 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Innospire Elegance	2007-12-07
PMN K042655 | BTI Rodney D. Mell [Philips Medical Systems International BV]	Innospire Essence	2007-12-07
PMN K042655 | BTI Rodney D. Mell [Philips Medical Systems International BV]	Innospire Elegance	2007-12-07
PMN K870514 | BWF Rodney D. Mell [Philips Medical Systems International BV]	Threshold IMT	2007-09-14
PMN K870514 | BWF Rodney D. Mell [Philips Medical Systems International BV]	Threshold IMT	2007-09-14
PMN K023135 | CBK Rodney D. Mell [Philips Medical Systems International BV]	ComfortGel Blue SE FFM	2007-07-05
PMN K023135 | CBK Rodney D. Mell [Philips Medical Systems International BV]	Amara View SE FFM	2007-07-05
PMN K982283 | BYE Rodney D. Mell [Philips Medical Systems International BV]	WhisperFlow Procedure Packs	2006-09-12
PMN K950397 | BYE Rodney D. Mell [Philips Medical Systems International BV]	CPAP VALVES	2006-09-12
PMN K032809 | CAF Rodney D. Mell [Philips Medical Systems International BV]	ProChamber Valved Holding Chamber	2004-11-09
BYG Rodney D. Mell [Philips Medical Systems International BV]	System 22 Aerosol Mask	2002-02-05
CAI Rodney D. Mell [Philips Medical Systems International BV]	Patient Circuits	2000-07-21
PMN K991725 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Reusable Neb and Masks	1999-11-01
PMN K991725 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Reusable Neb and Masks	1999-11-01
PMN K924123 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Disposable Neb and Masks	1999-11-01
PMN K924123 | CAF Rodney D. Mell [Philips Medical Systems International BV]	Sidestream Disposable Neb and Masks	1999-11-01
PMN K052941 | CAF Rodney D. Mell [Philips Medical Systems International BV]	I-Neb AAD Nebulizer w/Insight SW or Components	1995-04-21