FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012450012
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
950X00
Catalog number
950X00
Device description
Expiratory Heater Wire Adapter
Published
2023-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K220703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220703000F&P 950 Respiratory HumidifierFisher & Paykel Healthcare2023-06-16BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012450012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012450012094200124500129420012450012

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09420012474643F&P 850850A61J850A61J2026-04-13
09420012405890Fisher & Paykel Healthcare900HC031900HC0312026-04-08
09420012409690Fisher & Paykel Healthcare900RD302900RD3022026-04-08
09420012416728Fisher & Paykel Healthcare900HC033900HC0332026-04-08
09420012425911Fisher & Paykel HealthcareOPT31POPT31P2026-04-08
09420012425928Fisher & Paykel HealthcareOPT31NOPT31N2026-04-08
09420012430410Fisher & Paykel HealthcareRT205RT2052026-04-08
09420012449818Fisher & Paykel HealthcareRT331RT3312026-04-08
09420012429810FISHER & PAYKEL HEALTHCARE RT008RT0082015-09-25
09420012416810Fisher & Paykel HealthcareHC550JHUHC550JHU2016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012474643F&P 850FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-13
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012430410Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012449818Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012465849Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012471918Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012481740F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481795F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344005994HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344009824HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009589HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009817HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-04-05
10193489149296HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-11-22
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
09420012461452F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012461469F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476555F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476579F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476593F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012477910F&P Optiflow THRIVEFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
10193489149302HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
10193489149562HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
09420012463814Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-04-30
09420012474155Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-04-30