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

Aspen - 00833224000750 Catalog Number : ASP203

Device Description : Aspen Full Face Mask - MD

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Aspen - 00833224000767 Catalog Number : ASP205

Device Description : Aspen Full Face Mask - LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Aspen - 00833224000774 Catalog Number : ASP211

Device Description : Aspen Cushion - SM

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Aspen - 00833224000781 Catalog Number : ASP213

Device Description : Aspen Cushion - MD

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Aspen - 00833224000798 Catalog Number : ASP215

Device Description : Aspen Cushion - LG

Device Class :

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Nasal-Aire II - 00833224000842 Catalog Number : CXS1P

Device Description : Nasal-Aire II Critical Care – XS (with Port)

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Nasal-Aire II - 00833224000859 Catalog Number : CSM2P

Device Description : Nasal-Aire II Critical Care – SM (with Port)

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Nasal-Aire II - 00833224000866 Catalog Number : CMD3P

Device Description : Nasal-Aire II Critical Care – MD (with Port)

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Nasal-Aire II - 00833224000873 Catalog Number : CMP4P

Device Description : Nasal-Aire II Critical Care – MP (with Port)

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Nasal-Aire II - 00833224000880 Catalog Number : CLG5P

Device Description : Nasal-Aire II Critical Care – LG (with Port)

Device Class : 2

Duns Number: 103307950

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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