Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008264065

FEI Number

3008264065

Entity Name

Fisher & Paykel Healthcare S.A.de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Av. Todos los Santos #12831, Parque Industrial Pacifico, Tijuana Baja California 22643, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FISHER & PAYKEL HEALTHCARE NZ LTD (Owner Number: 8040217)

Owner / Operator Contact Address

15 MAURICE PAYKEL PLACE, EAST TAMAKI, AUCKLAND, NZ-NOTA 2013, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Optiflow Junior 2/2+ Interface Range FlexiFit Series HC431 Flexifit Full Face Mask RT045XS/S/M/L RT055XS/S/M/L Eson Mask F&P Eson Nasal Mask OptiNIV F&P Eson 2 ESON2 Nasal Mask Fit Pack ESN2SML ESON2 Nasal Mask Fit Pack FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen MR290 Humidification Chamber Icon Heated Breathing Tube Infosmart Software package ICON+ Novo CPAP ICON+ Auto CPAP 900ICON208 ThermoSmart Breathing Tube InfoUSB2 Infosmart CD Oxygen Elbow SmartStick Net Icon Chamber ICON+ Premo CPAP 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 Visairo RT077 Visairo RT076 Visairo RT075 RT020 End Expiratory Filter RT047XS/S/M/L RT057XS/S/M/L 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 Airvo 3 OptiPAP Junior 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 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 myAirvo Optiflow F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace RT016 Filter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-04-18
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-18
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2017-09-03
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-10-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-11-30
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-09-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2001-06-25
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-04-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-08-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2021-04-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-28
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2020-03-15
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2019-10-14
QAV	High Flow/High Velocity Humidified Oxygen Delivery Device	Anesthesiology	Class 2	868.5454	2023-02-14
SGR	Noninvasive Positive Airway Pressure System, Facility Use	Anesthesiology	Class 2	868.5895	2025-11-30
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2005-08-22
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-18
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-09-10
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-04-20
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2014-07-30

Official Correspondent

Brian Schultz

US Agent Details

Diego Vargas Banuelos Business: FISHER & PAYKEL LIMITED HEALTHCARE Email: Diego.VargasBanuelos@fphcare.com Phone: (949) 4341005

Related Public Records

Same Entity

FISHER & PAYKEL HEALTHCARE NZ LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015928685	FISHER & PAYKEL HEALTHCARE S.A.DE C.V.	Tijuana, Baja California, MX
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.

Similar Registrations

Registration Number	Establishment Name	Location
3010063021	TNI MEDICAL AG	Wurzburg Bavaria, DE
2085602	FISHER & PAYKEL HEALTHCARE, INC.	IRVINE, CA, US
3029906224	Hamilton Medical AG	Domat/Ems Graubunden, CH
3011137372	Teleflex Medical LLC	Morrisville, NC, US
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008264065. Last updated year: 2026. Please use registration number 3008264065 when referencing this establishment in official correspondence.