FDA Registration Active 🇳🇿 New Zealand

FISHER & PAYKEL HEALTHCARE, LTD.

Reg #: 9611451 · FEI: 3002806988 · Expires 2026
Products
36
Proprietary Names
292
Establishment Types
5
Classifications
36

Registration Details

Registration Name
FISHER & PAYKEL HEALTHCARE, LTD.
Registration Number
9611451
FEI Number
3002806988
Status
Active
Expiry Year
2026
Initial Importer
No
Address
15 MAURICE PAYKEL PLACE
City
EAST TAMAKI Auckland
Country
NZ

Regulatory Submissions

510(k) Number
K252173

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
Correspondent
Brian Schultz

US Agent

Business Name
FISHER & PAYKEL LIMITED HEALTHCARE
Contact Name
Diego Vargas Banuelos
Address
17400 Laguna Canyon Road., SUITE 300, Irvine
City
Irvine
State
CA
ZIP
92618
Country
US
Phone
949 4341005

Products

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

Proprietary Names

OptiNIV OptiPAP Junior Propre Waterfeed set 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) Airvo Nebulizer Adapter Evaqua Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer F&P Optiflow Oxygen Kit 900HC451 Oracle Opus Nasal Pillows Mask HC482 Opus Nasal Pillows Zest Petite Lady Zest Q Headgear - Rose Zest Q Zest Petite Nasal Mask Air entrainer neoweigh Infant Scales Trache direct connection Airway connectors 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 neoBLUEmini LED Phototherapy System IW980JEU Wall Mount Warmer Baby IW990JEU Wall Mount Warmer Manual Oxygen/Pressure Port Connector Oracle 452 HC451 Oracle F&P Optiflow Flow Diverter 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 Zest Plus Zest Zest Q Plus Zest Nasal Mask Tee drains (water traps) Airvo 3 RT045XS/S/M/L RT055XS/S/M/L Airvo 2 Series Humidifier PT101US Airvo 2 Humidifier myAIRVO 2 HUMIDIFIER Chamber Reusable for HC600 Series HEATED BREATHING TUBE AND CHAMBER KIT HEATED BREATHING TUBE PT100US myAirvo 2 Humidifier Tube and Chamber Kit (Junior) Disinfection kit WATERBAG AIRVO 2 HUMIDIFIER AUTOFEED CHAMBER Smartstick Auto CPAP Humidifier Performance Maximiser CPAP Humidifier HC254 Sleepstyle 200 Auto AIRVO Humidifier myAIRVO Humidifier Eson Mask F&P Eson Nasal Mask HumiGard Chamber Reuseable ThermoSmart Water Chamber for Humidified CPAP HC600 Series CPAP Humidifier MR730 Respiratory Humidifier Tube Bonnet BC3020-10 Chin Strap Mask interface adaptor Head Gear Chamber Connector ADAPTOR KITS MIDLINE PATIENT INTERFACE 850 AirSpiral Adult NIV and NHF Circuit Kit Face Mask Non Vented Fisher & Paykel Healthcare 850 Respiratory Humidifier RT020 End Expiratory Filter Paediatric analog vacuum Paediatric digital vacuum Venturi Backpack Suction Assembly Amvex Vacuum Regulator Digi/Analg Amvex Venturi backpack suction MR290 Humidification Chamber Breathing tube supports 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 Infant Evaqua 2 (RT265/RT266) FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen NeoWrap Occlusive Wrap 25x NeoWrap Occlusive Wrap 10x NeoWrap Polyethylene Occlusive Wrap Starter Kit NeoWrap FPH Bubble CPAP System FlexiFit Series HC431 Flexifit Full Face Mask 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 Optiflow Air/Oxygen Flow Source Optiflow myAirvo 3 F&P 950 Respiratory Humidifier F&P 950 MR410 Respiratory Humidifier NS232 Nerve Locator NS272 Nerve Locator and Stimulator 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 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 F&P Brevida™ Nasal Pillows Mask Infosmart Software package MR850 Resipiratory Humidifier F&P Nova Nasal 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 COSYCOT WARMER IW931JEU IW932JEU IW933JEU IW934JEU IW951JEU IW952JEU IW953JEU IW954JEU Pressure Gauge InfoGSM InfoSmart Web OJR215 Pressure Relief Manifold Oxygen Flowmeter Nipple - Green(900IW119G) Amvex flowmeters Optiflow Oxygen Kit MR850 Respiratory Humidifier Airvo 3 NIV HC500 Respiratory Humidifier F&P SleepStyle Auto CPAP, F&P SleepStyle CPAP, Thermosmart Breathing Tube, Standard Breathing Tube, Water Chamber F&P Nova Micro PIllows Mask F&P Nova Micro Pressure Manifold NS242 Peripheral Nerve Stimulator F&P Evora Nasal Mask NS252 Nerve Stimulator RT047XS/S/M/L RT057XS/S/M/L Bio-Med Inc. air/oxygen blender BC506-01 F&P Evora Full Mask F&P Eson 2 ESON2 Nasal Mask Fit Pack ESN2SML ESON2 Nasal Mask Fit Pack F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility 900RT008 AIR ENTRAINER Anesthesia breathing circuits Sleepstyle 200 Series RT016 Filter 900ICON203 InfoUSB2 INFOUSB_METRO InfoUSB INFOUSB_2 InfoUSB2 INFOUSB_MAC InfoUSB2 InfoUSB software Bird Gas Blender 900MR810 Adult Single Limb Circuit MR810 Respiratory Humidifier F&P 950 Bubble CPAP Breathing Circuit Kits IW910JEU MOBILE WARMER BABY W920JEU MOBILE WARMER MANUAL Optiflow Junior 2/2+ Interface Range 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 MR850 + Smart Adaptor RT043S, RT043M, RT043L (Single Use - Hospital Full Face Masks) RT040S, RT040M, RT040L Titration Compliance Maximiser Standard CPAP Kit Sleepstyle Titration Kit Heated Humidification Kit HC230 Series CPAP Humidifier Visairo RT077 Visairo RT076 Visairo RT075 HC550 Humidifier (HC550JHU) 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 Switch+ Optiflow Switch+ F&P 820 Humidification System Optiflow Asymmetric Interface Optiflow Luer Tee Optiflow 3S Nasal Cannula F&P Solo Mask Range 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 RT046XS/S/M/L RT056XS/S/M/L AirSpiral Heated Breathing Tube Optiflow Patient Interface Inspiratory/Expiratory Filter Heated Respiratory Humidifier Starter Kit Humid Universal Chamber Kit Humidification Chamber HC150 Humidifier myAirvo Regulator pin Amvex gas regulator F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace 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

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device