FISHER & PAYKEL HEALTHCARE LIMITED

Address:15 MAURICE PAYKEL PLACE,EAST TAMAKI Auckland,NZ

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (9) Ventilator, Non-Continuous (Respirator) (BZD) (1)

Premarket Exempt

No Yes

Clear

Fisher & Paykel Healthcare - 09420012467560 Catalog Number : MYAIRVOCHAMBER1

Device Description : myAirvo Reusable Chamber

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012469021 Catalog Number : 850A61J

Device Description : F&P 850 AirSpira Adult NIV and NHF circuit kit

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012469663 Catalog Number : MYOPT9SMALL

Device Description : Optiflow+ Nasal Cannula Small myAIRVO2-Pack

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012469687 Catalog Number : MYOPT9MEDIUM

Device Description : Optiflow+ Nasal Cannula Medium myAIRVO2-Pack

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012469700 Catalog Number : MYOPT9LARGE

Device Description : Optiflow+ Nasal Cannula Large myAIRVO2-pack

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012470126 Catalog Number : MYOPT9TRACHE

Device Description : Optiflow+ Tracheostomy Interface myAIRVO2-pack

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012470140 Catalog Number : MYOPT9MASK

Device Description : Optiflow+ Mask Interface myAIRVO2-pack

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher and Paykel Healthcare - 09420012470232 Catalog Number : MYAIRSPIRAL

Device Description : AirSpiral Tube myAIRVO

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012470928 Catalog Number : AA031JS

Device Description : Optiflow Nasal Filtered Interface with CO2 Sampling Small

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012470942 Catalog Number : AA031JM

Device Description : Optiflow Nasal Filtered Interface with CO2 Sampling Medium

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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