COMPASS HEALTH BRANDS CORP.

Address:6753 Engle Rd,Middleburg Heights,OH,44130,US

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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

Nebulizer (Direct Patient Interface) (CAF) (4) Compressor, Air, Portable (BTI) (3) Mattress, Air Flotation, Alternating Pressure (FNM) (3)

Premarket Exempt

No Yes

Clear

American Bantex - 00092237602294 Catalog Number :

Device Description : Pressure pump and mattress

Device Class : 2

Duns Number: 827221698

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602959 Catalog Number :

Device Description : Deluxe 8 Alt Pressure Pump

Device Class : 2

Duns Number: 827221698

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602966 Catalog Number :

Device Description : Altus Pro True Low Air Loss

Device Class : 2

Duns Number: 827221698

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237603031 Catalog Number :

Device Description : SierraNeb 2 Nebulizer Compressor

Device Class :

Duns Number: 827221698

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603048 Catalog Number :

Device Description : Roscoe Dinosaur Nebulizer

Device Class : 2

Duns Number: 827221698

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603062 Catalog Number :

Device Description : NEB-BUNNY

Device Class : 2

Duns Number: 827221698

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603123 Catalog Number :

Device Description : Roscoe Portable Nebulizer

Device Class :

Duns Number: 827221698

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603178 Catalog Number :

Device Description : TruNeb Reusable Neb Kit

Device Class : 2

Duns Number: 827221698

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603208 Catalog Number :

Device Description : Bunny Nebulizer Compressor System

Device Class :

Duns Number: 827221698

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603215 Catalog Number :

Device Description : Dino Pediatric Nebulizer Compressor

Device Class :

Duns Number: 827221698

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

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