FDA.reportPublic FDA data

F&P Optiflow

Primary DI
09420012480729
Brand
F&P Optiflow
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
AA484J
Catalog number
AA484J
Device description
F&P 820 Optiflow Oxygen Kit
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K211096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211096000Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.2022-01-28BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012480736PackageGS110In Commercial Distribution
09420012480729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012480736094200124807369420012480736
09420012480729094200124807299420012480729

GMDN Terms#

Term, Definition table
TermDefinition
Humidified oxygen administration setA collection of consumable devices designed to work together to deliver humidified pure oxygen (O2) or an O2 enriched gas to a mask or nasal cannula during oxygen administration to a patient (e.g., oxygen therapy, anaesthesia). It includes oxygen administration tubing (inspiratory line, dryline) which includes an electronic component (e.g., temperature sensor, heating wire), an inspiratory line humidification chamber, and may include a water bag. This is a reusable device.

Storage And Handling#

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

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
No natural rubber latex
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
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
10197344009831HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-03-24
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