FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012466679
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
PT311US
Catalog number
PT311US
Device description
Airvo 3 NIV Respiratory Support Device
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233643000F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.2024-08-09MNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012466679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012466679094200124666799420012466679

GMDN Terms#

Term, Definition table
TermDefinition
Professional BPAP/high-flow respiratory unitAn electrically-powered device designed to deliver heated and humidified ambient air or air/oxygen to a patient during both: 1) high-flow (exceeding peak inspiratory flow) respiratory therapy; and 2) bi-level positive airway pressure (BPAP). It consists of a gas flow generator that entrains room air, an oxygen input, a heating element, humidification chamber, and both pressure and flow sensors. It is intended for use by a healthcare provider on a spontaneously breathing patient.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
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
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465511Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480866Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
08401934313389ResScanRESMED CORP.MNT2023-02-24
08401934313396ResScanRESMED CORP.MNT2023-02-24
09420012455000Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455062Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455338Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455727Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459695Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460295Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460615Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460639Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460738Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460752Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460776Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460790Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
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00606959049024DreamMapper Web (DM)Respironics, Inc.MNT2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNT2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNT2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNT2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNT2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNT2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNT2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNT2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959053045DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959054844DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959058552EncoreAnywhereRespironics, Inc.MNT2019-12-29
00606959058569EncoreAnywhereRespironics, Inc.MNT2019-12-29