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 QUATTRO - 00619498161294 Catalog Number : 16129

Device Description : COMMON HG SML NAVY - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE QUATTRO - 00619498161300 Catalog Number : 16130

Device Description : COMMON HG STD NAVY - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MIRAGE QUATTRO - 00619498161317 Catalog Number : 16131

Device Description : COMMON HG LGE NAVY - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

QUATTRO AIR - 00619498161324 Catalog Number : 16132

Device Description : AIRFIT F10 SML HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

QUATTRO AIR - 00619498161331 Catalog Number : 16133

Device Description : AIRFIT F10 STD HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT F 10 - 00619498161348 Catalog Number : 16134

Device Description : AIRFIT F10 LGE HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT F20 - 00619498161355 Catalog Number : 16135

Device Description : AIRFIT F20 SML HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT F20 - 00619498161362 Catalog Number : 16136

Device Description : AIRFIT F20 STD HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT F20 - 00619498161379 Catalog Number : 16137

Device Description : AIRFIT F20 LGE HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

AIRFIT N 10 - 00619498161386 Catalog Number : 16138

Device Description : AirFit N10 SML Headgear - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

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