FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012470737
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900PT475
Catalog number
900PT475
Device description
Airvo 3 Suite Service Application
Published
2023-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAVHigh Flow/High Velocity Humidified Oxygen Delivery DeviceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09420012470737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012470737094200124707379420012470737

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment inventory management/maintenance softwareAn application software program intended to be used to manage data pertaining to the use, maintenance and servicing of medical devices and equipment, namely relating to one or more of the following: device electronic registration, inventory management, device identifiers, maintenance and servicing, spare parts ordering, equipment assessment, renewal planning or authority auditing, onboarding, firmware updating, and device diagnostic data submission to the manufacturer. It may be referred to as a medical equipment management system (MEMS) and is typically used by a clinical engineering department.

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
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
09420012477873F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2026-01-28
09420012474629Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2025-08-13
09420012474421Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2025-08-13
00841737105831VapothermVAPOTHERM, INC.QAV2025-03-11
00841737105817VapothermVAPOTHERM, INC.QAV2024-09-09
00841737105800VapothermVAPOTHERM, INC.QAV2024-08-26
00841737105787VapothermVAPOTHERM, INC.QAV2024-06-10
00841737105794VapothermVAPOTHERM, INC.QAV2024-06-10
00841737105763VapothermVAPOTHERM, INC.QAV2024-06-03
00841737105770VapothermVAPOTHERM, INC.QAV2024-06-03
09420012479631Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2024-03-28
09420012466518F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466525F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-24
09420012466662Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470010Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
09420012470744F&P Airvo 3FISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-04-05
00841737105480VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105497VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105503VapothermVAPOTHERM, INC.QAV2022-03-03
00841737105367VapothermVAPOTHERM, INC.QAV2021-11-15
00841737105374VapothermVAPOTHERM, INC.QAV2021-11-15
00841737105381VapothermVAPOTHERM, INC.QAV2021-11-15
00841737105336VapothermVAPOTHERM, INC.QAV2021-11-11
00841737105350VapothermVAPOTHERM, INC.QAV2021-11-11
00841737105008VapothermVAPOTHERM, INC.QAV2021-09-13
00841737104780VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104797VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104803VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104810VapothermVAPOTHERM, INC.QAV2021-07-15
00841737104827VapothermVAPOTHERM, INC.QAV2021-07-15