FISHER & PAYKEL HEALTHCARE LIMITED

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

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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

Ventilator, Non-Continuous (Respirator) (BZD) (3) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (1)

Premarket Exempt

No Yes

Clear

Fisher & Paykel Healthcare - 09420012471772 Catalog Number : EVF1MSLA

Device Description : F&P Evora Full Face PAP Therapy Mask - Small-Medium SLA

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012471789 Catalog Number : EVF1LSLA

Device Description : F&P Evora Full Face PAP Therapy Mask - Large SLA

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012471796 Catalog Number : EVF1XMLSLA

Device Description : F&P Evora Full Face PAP Therapy Mask - Fit Pack XS/S-M/L SLA

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Fisher & Paykel Healthcare - 09420012471826 Catalog Number : AA001JL

Device Description : Optiflow Filtered Nasal Interface Large

Device Class : 2

Duns Number: 590153276

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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