RESMED ASIA PTE. LTD.

Address:3 Tuas Avenue 2,Singapore South West,SG

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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

Generator, Oxygen, Portable (CAW) (6)

Premarket Exempt

Clear

Oxyensure - 09353645401000 Catalog Number :

Device Description : Oxyensure POC

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : Yes

Device Count : 1

Oxyensure Backpack - 09353645401024 Catalog Number :

Device Description : Oxyensure POC Backpack (AMO)

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

Oxyensure Mounting Straps - 09353645401048 Catalog Number :

Device Description : Oxyensure POC Mounting Straps (AMO)

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

Oxyensure Carry Bag - 09353645401055 Catalog Number :

Device Description : Oxyensure POC Carry Bag

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

Oxyensure AC/DC Charger US - 09353645401062 Catalog Number :

Device Description : Oxyensure POC AC/DC Charger US (AMO)

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

Oxyensure Charger DC/DC - 09353645401079 Catalog Number :

Device Description : Oxyensure POC Charger DC/DC

Device Class : 2

Duns Number: 659276906

Premarket Exempt : No

Product Code : CAW

Prescription Use : No

Device Count : 1

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