FDA.reportPublic FDA data

Fisher & Paykel Healthcare

Primary DI
09420012474421
Brand
Fisher & Paykel Healthcare
Company
FISHER & PAYKEL HEALTHCARE LIMITED
Model
900PT620
Catalog number
900PT620
Device description
Airvo 3 Disinfection Kit US
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
09420012474421PackageGS110In Commercial Distribution
09420012474629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09420012474421094200124744219420012474421
09420012474629094200124746299420012474629

GMDN Terms#

Term, Definition table
TermDefinition
Dry-heat humidifier disinfection tubeA non-sterile, electrically-powered device intended for total elimination and/or inactivation of microorganisms from non-heat sensitive component(s) of humidifiers designed for dry-heat, high-level disinfection to comply with established infection control practices for respiratory devices used on multiple patients. It consists of a flexible tube that connects between the breathing tube components of the humidifier electrical control unit to create a circuit through which forced air is circulated and heated to the appropriate temperature by its integral electrical heating element. The process is controlled by the humidifier electrical control unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1800 446 3908Customer.CareUSA@fphcare.com

Regulatory Flags#

DUNS number
590153276
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09420012432070Fisher and Paykel HealthcareOPT542OPT5422022-08-02
09420012432087Fisher and Paykel HealthcareOPT544OPT5442022-08-02
09420012432094Fisher and Paykel HealthcareOPT546OPT5462022-08-02
09420012432100Fisher & Paykel HealthcareOPT570OPT5702023-07-06
09420012480729F&P OptiflowAA484JAA484J2025-11-07
09420012433831Fisher & Paykel HealthcareAA400SUAA400SU2016-09-08
09420012424808Fisher & Paykel HealthcareOPT870EOPT870E2023-07-06
09420012432148Fisher & Paykel HealthcareOPT870OPT8702023-07-06
09420012432162Fisher & Paykel HealthcareRT241RT2412022-08-02
09420012414557Fisher & Paykel Healthcare900MR441900MR4412022-08-02
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

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
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
09420012470737Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDQAV2023-09-13
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