RESMED PTY LTD

Address:1 ELIZABETH MACARTHUR DRIVE,BELLA VISTA New South Wales,AU

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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

Ventilator, Non-Continuous (Respirator) (BZD) (7)

Premarket Exempt

No Yes

Clear

AirFit N30 - 00619498642212 Catalog Number : 64221

Device Description : AIRFIT N30 FRAME MULTIHOLE SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirFit N30 - 00619498642229 Catalog Number : 64222

Device Description : AIRFIT N30 MASK SYSTEM S - AMER

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit N30 - 00619498642236 Catalog Number : 64223

Device Description : AIRFIT N30 MASK SYSTEM M - AMER

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit N30 - 00619498642243 Catalog Number : 64224

Device Description : AIRFIT N30 MASK SYSTEM SW - AMER

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit N30 - 00619498642304 Catalog Number : 64230

Device Description : AIRFIT N30 MASK SYSTEM SLM - S

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit N30 - 00619498642311 Catalog Number : 64231

Device Description : AIRFIT N30 MASK SYSTEM SLM - M

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit N30 - 00619498642328 Catalog Number : 64232

Device Description : AIRFIT N30 MASK SYSTEM SLM - SW

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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