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

MIRAGE MICRO - 00619498163892 Catalog Number : 16389

Device Description : MIRAGE MICRO CUSHION MED

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163908 Catalog Number : 16390

Device Description : MIRAGE MICRO CUSHION LG

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163915 Catalog Number : 16391

Device Description : MIRAGE MICRO CUSHION LG-WD

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163922 Catalog Number : 16392

Device Description : MIRAGE MICRO CUSHION XL

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163939 Catalog Number : 16393

Device Description : MIRAGE MICRO FOREHEAD SUPPORT

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163946 Catalog Number : 16394

Device Description : MIRAGE MICRO MASK FRAME STANDARD

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163953 Catalog Number : 16395

Device Description : MIRAGE MICRO MASK FRAME SMALL

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE ACTIVA LT - 00619498163991 Catalog Number : 16399

Device Description : MIRAGE ACTIVA LT ELBOW ASSEMBLY

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

UM FFM - 00619498165094 Catalog Number : 16509

Device Description : MIRAGE AIR VENT - SINGLE PACK

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

ULTRA MIRAGE II - 00619498165483 Catalog Number : 16548

Device Description : ULTRA MIRAGE II MASK SYS STD-USA

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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