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
- [email protected]
- Phone
- 949 4341005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-11-30 |
| Noninvasive Positive Airway Pressure System, Facility Use | SGR | Class 2 | Anesthesiology | No | 2025-11-30 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2016-04-13 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2008-07-10 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2009-01-20 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2022-01-13 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2008-01-29 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2007-12-02 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2008-02-18 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2007-11-28 |
| Scale, Patient | FRW | Class 1 | General Hospital | No | 2008-01-23 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2009-01-20 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2008-02-12 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2024-08-29 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2009-01-20 |
| High Flow/High Velocity Humidified Oxygen Delivery Device | QAV | Class 2 | Anesthesiology | No | 2023-02-14 |
| Sv70 Ventilator | MNT | Class 2 | Anesthesiology | No | 2017-09-03 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2017-07-17 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2002-07-29 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-11-28 |
| Regulator, Vacuum | KDP | Class 2 | General Hospital | No | 2008-08-19 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2009-01-20 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2001-06-25 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2004-05-21 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2007-11-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2009-08-04 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2009-01-20 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2005-08-22 |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | Class 1 | Anesthesiology | No | 2009-01-27 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2009-01-21 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2008-02-11 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 1995-08-31 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2009-01-20 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-07-16 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2009-01-29 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2007-12-02 |
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