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) (10)

Premarket Exempt

No Yes

Clear

AirTouch N20 - 00619498639502 Catalog Number : 63950

Device Description : AIRTOUCH N20 CUSHION SML

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639519 Catalog Number : 63951

Device Description : AIRTOUCH N20 CUSHION MED

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639526 Catalog Number : 63952

Device Description : AIRTOUCH N20 CUSHION LGE

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639533 Catalog Number : 63953

Device Description : AIRTOUCH N20 FRAME SYS - SML

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639540 Catalog Number : 63954

Device Description : AIRTOUCH N20 FRAME SYS (FH) SML

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639557 Catalog Number : 63955

Device Description : AIRTOUCH N20 FRAME SYS - MED

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirTouch N20 - 00619498639564 Catalog Number : 63956

Device Description : AIRTOUCH N20 FRAME SYS - LGE

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AirFit F30 - 00619498641000 Catalog Number : 64100

Device Description : AirFit F30 SML SYS

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit F30 - 00619498641017 Catalog Number : 64101

Device Description : AIRFIT F30 MED SYS

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

AirFit F30 - 00619498641048 Catalog Number : 64104

Device Description : AIRFIT F30 SML SYS - SLM

Device Class :

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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