Faranak Gomarooni

FDA Filings

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

FDA Registration(s)
Registration Number3015928685
FEI Number3015928685
NameFARANAK GOMAROONI
Owner & OperatorFISHER & PAYKEL HEALTHCARE NZ LTD
Contact Address15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND NZ-NOTA 2013 NZ
Official Correspondent
  • Brian Schultz
  • 64-9-5740100-8314
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address173 TECHNOLOGY DR. , SUITE 100 Irvine
Irvine, CA 92618 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3008264065
FEI Number3008264065
NameFaranak Gomarooni
Owner & OperatorFISHER & PAYKEL HEALTHCARE NZ LTD
Contact Address15 MAURICE PAYKEL PLACE
EAST TAMAKI, AUCKLAND NZ-NOTA 2013 NZ
Official Correspondent
  • Brian Schultz
  • 64-9-5740100-8314
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address173 Technology Dr. Suite 100
Irvine, CA 92618 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT047XS2020-03-15
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT047S2020-03-15
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT047M2020-03-15
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT047L2020-03-15
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Small Sleep Lab2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Small A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Medium Sleep Lab2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Medium A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Med/Lrg Sleep Lab2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Large Sleep Lab2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Full Face Large A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Fitpack Sml/Med/Lrg A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Dbl Seal Sml/Sml A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Dbl Seal Med/Med A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Vitera Mask Dbl Seal Lrg/Lrg A Model2019-10-14
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Optiflow Patient Interface2018-12-20
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
AirSpiral Heated Breathing Tube2018-12-20
FARANAK GOMAROONI [FISHER & PAYKEL HEALTHCARE NZ LTD]
Optiflow Patient Interface2018-12-20
FARANAK GOMAROONI [FISHER & PAYKEL HEALTHCARE NZ LTD]
AirSpiral Heated Breathing Tube2018-12-20
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT046XS2018-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT046S2018-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT046M2018-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT046L2018-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT045XS2017-09-03
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT045S2017-09-03
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT045M2017-09-03
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT045L2017-09-03
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Eson 22016-09-20
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ESON2 Nasal Mask Fit Pack2016-09-20
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ESN2SML ESON2 Nasal Mask Fit Pack2016-09-20
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT016 Inspiratory Filter2014-07-30
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
SIMPLUS Full Face Mask Fit Pack SML2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Simplus Full Face Mask2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Simplus Full Face Mask SL - Small2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Simplus Full Face Mask SL - Medium2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Simplus Full Face Mask SL - Large2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400483FITPACK SIMPLUS Full Face Mask Fit Pack SML2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400477 F&P Simplus Full Face Mask - Large2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400476 F&P Simplus Full Face Mask - Medium2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400475 F&P Simplus Full Face Mask - Small2013-06-12
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT481 Care Continuum Kit- Vent Use2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT380 and RT385, 'Adult Evaqua 2' Dual Heated Breathing Circuits2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT332, 'MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow Nasal Cannula'2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT302 MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT232, 'Adult Optiflow Circuit Kit with MicroCell Technology2012-12-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
F&P Eson Nasal Mask2012-10-09
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Eson Mask2012-10-09
FARANAK GOMAROONI [FISHER & PAYKEL HEALTHCARE NZ LTD]
Infant Evaqua 2 (RT265/RT266)2012-08-09
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
SmartStick Net2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Oxygen Elbow2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Infosmart Software package2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Infosmart CD2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
InfoUSB22010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Icon Heated Breathing Tube2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Icon Chamber2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ICON+ Premo CPAP2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ICON+ Novo CPAP2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ICON+ Auto CPAP2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
900ICON208 ThermoSmart Breathing Tube2010-04-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
HC432 Flexifit Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400473SL Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400473A Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400471SL Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400471A Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400470SL Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
400470A Forma Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Flexifit Full Face Mask2008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
FlexiFit Series HC4312008-02-18
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
MR850 Resipiratory Humidifier2008-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Infosmart Software package2008-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
MR290 Humidification Chamber2008-01-29
FARANAK GOMAROONI [FISHER & PAYKEL HEALTHCARE NZ LTD]
MR290 Humidification Chamber2008-01-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT020 End Expiratory Filter2007-11-28
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
RT oxygen cannula2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Optiflow+ nasal cannula2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Optiflow oxygen cannula2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Nasal cannula small2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Nasal cannula medium2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Nasal cannula large2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Nasal cannula extra small2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Nasal cannula extra large2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
BC oxygen cannula2005-08-22
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Tube2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Mask interface adaptor2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
MIDLINE PATIENT INTERFACE2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Head Gear2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Chin Strap2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Chamber Connector2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Bonnet2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
BC3020-102002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
ADAPTOR KITS2002-07-29
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Mask Oxygen2001-06-25
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
FlexiFit 4072001-06-25
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
FlexiFit 407 (Sleep Lab)2001-06-25
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
FlexiFit 4062001-06-25
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
FlexiFit 405 (Sleep Lab)2001-06-25
Faranak Gomarooni [FISHER & PAYKEL HEALTHCARE NZ LTD]
Aclaim22001-06-25

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