Innomed Technologies Inc

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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

Clear

Sylent - 00833224000514 Catalog Number : SYL203

Device Description : Sylent 2 Nasal Mask - MD

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Sylent - 00833224000521 Catalog Number : SYL200

Device Description : Sylent Nasal Mask - All Sizes Kit

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Sylent - 00833224000538 Catalog Number : SYL211

Device Description : Sylent 2 Cushion - SM

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Sylent - 00833224000545 Catalog Number : SYL213

Device Description : Sylent 2 Cushion - MD

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Sylent NE - 00833224000569 Catalog Number : SYL271

Device Description : Sylent 2 NE Nasal Mask - SM

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Sylent NE - 00833224000576 Catalog Number : SYL273

Device Description : Sylent 2 NE Nasal Mask - MD

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Aloha - 00833224000590 Catalog Number : ALO100

Device Description : Aloha Nasal Pillows - All Sizes Kit

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Aloha - 00833224000606 Catalog Number : ALO121

Device Description : Aloha Pillows - SM

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Aloha - 00833224000613 Catalog Number : ALO123

Device Description : Aloha Pillows - MD

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Aloha - 00833224000620 Catalog Number : ALO125

Device Description : Aloha Pillows - LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

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