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

ULTRA MIRAGE II - 00619498165490 Catalog Number : 16549

Device Description : ULTRA MIRAGE II MASK SYS LGE -USA

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ULTRA MIRAGE II - 00619498165506 Catalog Number : 16550

Device Description : ULTRA MIRAGE II MASK SYS SHW-USA

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ULTRA MIRAGE II - 00619498165520 Catalog Number : 16552

Device Description : ULTRA MIRAGE II SLM-STD

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ULTRA MIRAGE II - 00619498165537 Catalog Number : 16553

Device Description : ULTRA MIRAGE II SLM - LGE

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

ULTRA MIRAGE II - 00619498165544 Catalog Number : 16554

Device Description : ULTRA MIRAGE II SLM-SHLW

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

UM/UMII - 00619498165568 Catalog Number : 16556

Device Description : UM/UMII CUSHION-STD

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

UM/UMII - 00619498165575 Catalog Number : 16557

Device Description : UM/UMII CUSHION LARGE

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

UM/UMII - 00619498165582 Catalog Number : 16558

Device Description : UM/UMII CUSHION SHALLOW

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

UM/UMII - 00619498165605 Catalog Number : 16560

Device Description : UM/UM II MASK FRAME

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

ULTRA MIRAGE - 00619498165612 Catalog Number : 16561

Device Description : ULTRA MIRAGE FOREHEAD PADS

Device Class :

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 2

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