BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FISHER & PAYKEL HEALTHCARE, INC.

    Reg #: 2085602 · FEI: 3000210616 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    292
    Establishment Types
    1
    Classifications
    36

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    FISHER & PAYKEL HEALTHCARE, INC.
    Registration Number
    2085602
    FEI Number
    3000210616
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    17400 Laguna Canyon Road, #300
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970432

    Owner / Operator

    Firm Name
    FISHER & PAYKEL HEALTHCARE NZ LTD
    Operator Number
    8040217
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI, AUCKLAND
    State
    NZ-NOTA
    Postal Code
    2013
    Country
    NZ

    Products

    Device Name Product Code
    Warmer, Infant Radiant FMT
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Cannula, Nasal, Oxygen CAT
    Tape And Bandage, Adhesive KGX
    Ventilator, Non-Continuous (Respirator) BZD
    Insufflator, Laparoscopic HIF
    Stimulator, Nerve, Peripheral, Electric KOI
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Regulator, Vacuum KDP
    Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
    Sv70 Ventilator MNT
    Stand, Infusion FOX
    Bedding, Disposable, Medical KME
    Mixer, Breathing Gases, Anesthesia Inhalation BZR
    Noninvasive Positive Airway Pressure System, Facility Use SGR
    Support, Breathing Tube JAY
    Unit, Neonatal Phototherapy LBI
    Filter, Bacterial, Breathing-Circuit CAH
    Mask, Oxygen, Low Concentration, Venturi BYF
    Ventilator, Continuous, Facility Use CBK
    Valve, Non-Rebreathing CBP
    Drain, Tee (Water Trap) BYH
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Mask, Oxygen BYG
    Generator, Oxygen, Portable CAW
    Stimulator, Nerve, Battery-Powered BXN
    Medical Device Data System OUG
    Gauge, Gas Pressure, Cylinder/Pipeline BXH
    Tubing, Pressure And Accessories BYX
    Connector, Airway (Extension) BZA
    Nebulizer (Direct Patient Interface) CAF
    Scale, Patient FRW
    High Flow/High Velocity Humidified Oxygen Delivery Device QAV
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Regulator, Pressure, Gas Cylinder CAN

    Proprietary Names

    IW910JEU MOBILE WARMER BABY W920JEU MOBILE WARMER MANUAL myAirvo Optiflow Nasal cannula large Nasal cannula small Nasal cannula medium Optiflow+ nasal cannula Nasal cannula extra large Nasal cannula extra small RT oxygen cannula Optiflow oxygen cannula BC oxygen cannula DaisyDot Sensor Cover DaisyDot Mini Sensor Cover Optiflow Junior 2 WigglewiNG XS S Optiflow Junior 2 WigglewiNG XXL Optiflow Junior 2 WigglewiNG M L XL F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility Eson Mask F&P Eson Nasal Mask Zest Petite Lady Zest Q Headgear - Rose Zest Q Zest Petite Nasal Mask Zest Nasal Mask HumiGard F&P Nova Micro PIllows Mask F&P Nova Micro NS232 Nerve Locator NS272 Nerve Locator and Stimulator MR850 Respiratory Humidifier Evaqua F&P 950 Respiratory Humidifier F&P 950 F&P Solo Mask Range Paediatric analog vacuum Paediatric digital vacuum Venturi Backpack Suction Assembly Amvex Vacuum Regulator Digi/Analg Amvex Venturi backpack suction 400473SL Forma Full Face Mask 400473A Forma Full Face Mask HC432 Flexifit Full Face Mask 400471A Forma Full Face Mask 400470A Forma Full Face Mask 400470SL Forma Full Face Mask 400471SL Forma Full Face Mask Fisher & Paykel Healthcare 850 Respiratory Humidifier InfoGSM InfoSmart Web HC451 Oracle Oxygen/Pressure Port Connector Oracle 452 Oxygen Flowmeter Nipple - Green(900IW119G) Amvex flowmeters FPH Bubble CPAP System 900MR810 Adult Single Limb Circuit MR810 Respiratory Humidifier Propre Infosmart Software package MR850 Resipiratory Humidifier MR410 Respiratory Humidifier Icon Heated Breathing Tube ICON+ Novo CPAP ICON+ Auto CPAP 900ICON208 ThermoSmart Breathing Tube InfoUSB2 Infosmart CD Oxygen Elbow SmartStick Net Icon Chamber ICON+ Premo CPAP Airvo 3 NIV Mobile pole stand Dual cylinder rack Cable/Hose Hook Mounting bracket for bird blender, includes CosyCot mounting block Compact Stand Accessory hook Humidifier Mounting Tray Side Mounting Block: Infant Resuscitator wall mount bracket Quad Hook Side Shelf and Support Block mounting bracket Pole Mounting Tray Suction canister mounting block Mounting pole long UPS Mounting Kit Single cylinder rack large Pole mounting tray Mounting pole short Dovetail Channel Rail Bracket Bird blender pole mount bracket Infusion stands Dovetail Rail (AA502) DIN Rail (AA501) Mounting Humidifier Pole (AA503) Optiflow Luer Tee Optiflow 3S Nasal Cannula MR290 Humidification Chamber NeoWrap Occlusive Wrap 25x NeoWrap Occlusive Wrap 10x NeoWrap Polyethylene Occlusive Wrap Starter Kit NeoWrap Bird Gas Blender OptiPAP Junior RT045XS/S/M/L RT055XS/S/M/L F&P Eson 2 ESON2 Nasal Mask Fit Pack ESN2SML ESON2 Nasal Mask Fit Pack Optiflow Oxygen Kit Breathing tube supports neoBLUEmini LED Phototherapy System myAirvo 3 RT020 End Expiratory Filter F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace F&P Evora Nasal Mask F&P Optiflow Oxygen Kit Opus Nasal Pillows Mask HC482 Opus Nasal Pillows HC550 Humidifier (HC550JHU) 900RT008 AIR ENTRAINER OptiNIV AirSpiral Heated Breathing Tube Optiflow Patient Interface F&P Optiflow Flow Diverter Tee drains (water traps) HC500 Respiratory Humidifier Airvo Series Humidifier Heated breathing tube Airvo disinfection kit Waterbag Airvo 2 (Junior tube and chamber) Autofeed Chamber Heated breathing tube and chamber PT100US myAirvo 2 Humidifier PT101US Airvo 2 Humidifier Optiflow Air/Oxygen Flow Source Vitera Mask Dbl Seal Sml/Sml A Model Vitera Mask Full Face Small Sleep Lab Vitera Mask Full Face Large Sleep Lab Vitera Mask Dbl Seal Med/Med A Model Vitera Mask Full Face Medium A Model Vitera Mask Dbl Seal Lrg/Lrg A Model Vitera Mask Fitpack Sml/Med/Lrg A Model Vitera Mask Full Face Small A Model Vitera Mask Full Face Medium Sleep Lab Vitera Mask Full Face Med/Lrg Sleep Lab Vitera Mask myStart Pack Sml/Med/Lrg A Model Vitera Mask Full Face Large A Model Inspiratory/Expiratory Filter Bio-Med Inc. air/oxygen blender BC506-01 F&P Evora Full Mask MR850 + Smart Adaptor Sleepstyle 200 Series CPAP Humidifier COSYCOT WARMER IW931JEU IW932JEU IW933JEU IW934JEU IW951JEU IW952JEU IW953JEU IW954JEU Resuscitation T-Piece Kit: Humidified resuscitation system Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 60mm Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 50mm Resuscitation T-Piece Kit: Single use T-Piece Circuit-Classic Neopuff T-piece infant resuscitator Resuscitation T-Piece Kit: Single use T-Piece-Classic F&P 950 Bubble CPAP Breathing Circuit Kits AIRVO Humidifier myAIRVO Humidifier OJR215 Pressure Relief Manifold 900HC451 Oracle Switch+ Optiflow Switch+ Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer Anesthesia breathing circuits F&P SleepStyle Auto CPAP, F&P SleepStyle CPAP, Thermosmart Breathing Tube, Standard Breathing Tube, Water Chamber RT046XS/S/M/L RT056XS/S/M/L FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen RT043S, RT043M, RT043L (Single Use - Hospital Full Face Masks) RT040S, RT040M, RT040L Smartstick Auto CPAP Humidifier Performance Maximiser HC254 Sleepstyle 200 Auto FlexiFit Series HC431 Flexifit Full Face Mask Waterfeed set F&P Nova Nasal Pressure Manifold F&P 820 Humidification System NS242 Peripheral Nerve Stimulator Optiflow Junior 2/2+ Interface Range NS252 Nerve Stimulator IW980JEU Wall Mount Warmer Baby IW990JEU Wall Mount Warmer Manual 900ICON203 InfoUSB2 INFOUSB_METRO InfoUSB INFOUSB_2 InfoUSB2 INFOUSB_MAC InfoUSB2 InfoUSB software Chamber Reuseable ThermoSmart Water Chamber for Humidified CPAP HC600 Series CPAP Humidifier Pressure Gauge Zest Plus Zest Zest Q Plus 400421SL F&P Pilairo Q Nasal Pillows Mask - SL F&P Pilairo Q Diffuser & Cover 400421 F&P Pilairo Q Nasal Pillows Mask Pilairo Pilairo Nasal Pillows Mask Suction accessory block Gas accessory block Gas supply module Gas low pressure module Neopuff Supply Line-Short Flowmeter Neopuff Supply Line-Long Amvex gas hoses Trache direct connection Airway connectors Airvo 2 Series Humidifier myAIRVO 2 HUMIDIFIER Chamber Reusable for HC600 Series HEATED BREATHING TUBE AND CHAMBER KIT HEATED BREATHING TUBE Tube and Chamber Kit (Junior) Disinfection kit WATERBAG AIRVO 2 HUMIDIFIER AUTOFEED CHAMBER MR730 Respiratory Humidifier Airvo Nebulizer Adapter RT016 Filter neoweigh Infant Scales Air entrainer Airvo 3 Optiflow Asymmetric Interface Heated Respiratory Humidifier Starter Kit Humid Universal Chamber Kit Humidification Chamber HC150 Humidifier 400475 F&P Simplus Full Face Mask - Small F&P Simplus Full Face Mask 400476 F&P Simplus Full Face Mask - Medium 400477 F&P Simplus Full Face Mask - Large F&P Simplus Full Face Mask SL - Small F&P Simplus Full Face Mask SL - Large F&P Simplus Full Face Mask SL - Medium 400483FITPACK SIMPLUS Full Face Mask Fit Pack SML SIMPLUS Full Face Mask Fit Pack SML Infant Evaqua 2 (RT265/RT266) Respiratory Humidifier F&P Brevida™ Nasal Pillows Mask Titration Compliance Maximiser Standard CPAP Kit Sleepstyle Titration Kit Heated Humidification Kit HC230 Series CPAP Humidifier Visairo RT077 Visairo RT076 Visairo RT075 850 AirSpiral Adult NIV and NHF Circuit Kit Tube Bonnet BC3020-10 Chin Strap Mask interface adaptor Head Gear Chamber Connector ADAPTOR KITS MIDLINE PATIENT INTERFACE RT047XS/S/M/L RT057XS/S/M/L Face Mask Non Vented Regulator pin Amvex gas regulator RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit RT302 MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula RT332, 'MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow Nasal Cannula' RT232, 'Adult Optiflow Circuit Kit with MicroCell Technology RT481 Care Continuum Kit- Vent Use RT380 and RT385, 'Adult Evaqua 2' Dual Heated Breathing Circuits

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198