FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012401519
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
MR225X
Catalog number
MR225X
Device description
Humidification Chamber
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913368000MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACCFisher & Paykel Electronics , Ltd.1992-01-13BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012401519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012401519094200124015199420012401519

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory line humidification chamber, single-useA device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800 446 3908Customer.CareUSA@fphcare.com

Regulatory Flags#

DUNS number
590153276
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012432070Fisher and Paykel HealthcareOPT542OPT5422022-08-02
09420012432087Fisher and Paykel HealthcareOPT544OPT5442022-08-02
09420012432094Fisher and Paykel HealthcareOPT546OPT5462022-08-02
09420012432100Fisher & Paykel HealthcareOPT570OPT5702023-07-06
09420012480729F&P OptiflowAA484JAA484J2025-11-07
09420012433831Fisher & Paykel HealthcareAA400SUAA400SU2016-09-08
09420012424808Fisher & Paykel HealthcareOPT870EOPT870E2023-07-06
09420012432148Fisher & Paykel HealthcareOPT870OPT8702023-07-06
09420012432162Fisher & Paykel HealthcareRT241RT2412022-08-02
09420012414557Fisher & Paykel Healthcare900MR441900MR4412022-08-02
09420012477477F&P OptiNIVONIV117AONIV117A2025-12-06
09420012477484F&P OptiNIVONIV117BONIV117B2025-12-06
09420012477491F&P OptiNIVONIV117CONIV117C2025-12-06
09420012480446F&P OptiNIVONIV117A-FONIV117A-F2025-12-06
09420012480460F&P OptiNIVONIV117B-FONIV117B-F2025-12-06
09420012480484F&P OptiNIVONIV117C-FONIV117C-F2025-12-06
09420012424815Fisher & Paykel HealthcareRT013ERT013E2022-08-02
09420012432155Fisher & Paykel HealthcareRT013RT0132022-08-02
09420012436047Fisher & Paykel HealthcareWJR210WJR2102026-04-14
09420012436061Fisher & Paykel HealthcareWJR212WJR2122026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561617NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561716NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561723NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561730NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561785NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561792NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561808NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561815NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561822NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561839NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561846NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561853NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561860NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20