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) (5) Tubing, Pressure And Accessories (BYX) (4) Strap, Head, Gas Mask (BTK) (1)

Premarket Exempt

No Yes

Clear

GRAY TUBING - 00619498149865 Catalog Number : 14986

Device Description : GRAY TUBING, CUFFED,6'6" (2 METERS)

Device Class : 1

Duns Number: 751149311

Premarket Exempt : No

Product Code : BYX

Prescription Use : No

Device Count : 1

CLEAR TUBING - 00619498149872 Catalog Number : 14987

Device Description : TUBING,CLEAR GREY RIBBED, 6'6" (2 METERS)

Device Class : 1

Duns Number: 751149311

Premarket Exempt : No

Product Code : BYX

Prescription Use : No

Device Count : 1

RESMED - 00619498149940 Catalog Number : 14994

Device Description : STANDARD TUBING, CLEAR-GRAY, 6' (1.83m)

Device Class : 1

Duns Number: 751149311

Premarket Exempt : No

Product Code : BYX

Prescription Use : Yes

Device Count : 1

RESMED - 00619498149995 Catalog Number : 14999

Device Description : STANDARD TUBING, CLEAR-GRAY, 9' (2.74m)

Device Class : 1

Duns Number: 751149311

Premarket Exempt : No

Product Code : BYX

Prescription Use : Yes

Device Count : 1

CHIN RESTRAINT - 00619498160150 Catalog Number : 16015

Device Description : CHIN RESTRAINT

Device Class : 1

Duns Number: 751149311

Premarket Exempt : Yes

Product Code : BTK

Prescription Use : No

Device Count : 1

MIRAGE / UM - 00619498161171 Catalog Number : 16117

Device Description : MIRAGE/UM NASAL MASK HG

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

HEADGEAR - 00619498161188 Catalog Number : 16118

Device Description : HEADGEAR SMALL

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

HEADGEAR - 00619498161195 Catalog Number : 16119

Device Description : HEADGEAR LARGE

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

QUATTRO AIR - 00619498161270 Catalog Number : 16127

Device Description : QUATTRO AIR SML HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

QUATTRO AIR - 00619498161287 Catalog Number : 16128

Device Description : QUATTRO AIR STD HEADGEAR - SLM

Device Class : 2

Duns Number: 751149311

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

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