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

Yes No

Clear

MIRAGE FX - 00619498161409 Catalog Number : 16140

Device Description : MIRAGE FX MASK HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT N20 - 00619498161416 Catalog Number : 16141

Device Description : AirFit N20 SML Headgear - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT N20 - 00619498161423 Catalog Number : 16142

Device Description : AirFit N20 STD Headgear - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT N20 - 00619498161430 Catalog Number : 16143

Device Description : AirFit N20 LGE Headgear - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

SWIFT FX - 00619498161454 Catalog Number : 16145

Device Description : Swift FX Short Tube ASSY SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

MIRAGE MICRO - 00619498163335 Catalog Number : 16333

Device Description : MIRAGE MICRO MASK SML

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE MICRO - 00619498163342 Catalog Number : 16334

Device Description : MIRAGE MICRO MASK MED & LG

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE MICRO - 00619498163359 Catalog Number : 16335

Device Description : MIRAGE MICRO MASK LG-WD & XL

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE MICRO - 00619498163755 Catalog Number : 16375

Device Description : MIRAGE MICRO SLM SML

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE MICRO - 00619498163762 Catalog Number : 16376

Device Description : MIRAGE MICRO SLM MED & LG

Device Class :

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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