FDA.reportPublic FDA data

F&P Optiflow

Primary DI
09420012480347
Brand
F&P Optiflow
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
AA600US
Catalog number
AA600US
Device description
F&P Optiflow Air/Oxygen Flow Source
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243917000F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.2025-07-14BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012480347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012480347094200124803479420012480347

GMDN Terms#

Term, Definition table
TermDefinition
Professional high-flow respiratory unit, non-humidifyingAn electrically-powered device that is a component of a high-flow respiratory assembly designed to generate a high-flow (exceeding peak inspiratory flow) of ambient air or air/oxygen for delivery to a patient in a peri-anaesthesia environment or experiencing a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), bronchiectasis, xerostomia, and mucositis]. It is a small unit with an integrated gas flow generator; it does not include a heater or humidifier. It is intended to be used by a healthcare provider as part of noninvasive ventilation (NIV).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1808 446 3908Customer.CareUSA@fphcare.com

Regulatory Flags#

DUNS number
590153276
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09420012429933FISHER & PAYKEL HEALTHCARE900RD010900RD0102015-09-25
09420012445445Fisher & Paykel HealthcareBC2425-20BC2425-202023-07-06
09420012407221MR850MR850AFUMR850AFU2016-09-08
09420012416797Fisher and Paykel HealthcareHC550AFUHC550AFU2022-08-02
09420012430700Fisher & Paykel HealthcareRT245RT2452022-08-02
09420012433145Fisher & Paykel HealthcareNC020-20NC020-202016-09-08
09420012433152Fisher & Paykel HealthcareNC021-20NC021-202016-09-08
09420012433930Fisher & Paykel Healthcare900MR161L900MR161L2022-08-02

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