Roscoe Medical

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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

Cushion, Wheelchair (IMP) (3) Ventilator, Non-Continuous (Respirator) (BZD) (3) Oximeter (DQA) (2) Compressor, Air, Portable (BTI) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

Roscoe Medical - 00092237603314 Catalog Number :

Device Description : Roscoe Alphaneb Plus Neb,

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603338 Catalog Number :

Device Description : Maverick 50 psi Hvy Dty

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : BTI

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603437 Catalog Number :

Device Description : Roscoe Full Face CPAP Mask

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603444 Catalog Number :

Device Description : Roscoe Full Face CPAP Mask

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603451 Catalog Number :

Device Description : Roscoe Full Face CPAP Mask

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603826 Catalog Number :

Device Description : Pediatric Pulse Oximeter,

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603833 Catalog Number :

Device Description : Roscoe Pulse Oximeter, Color

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Wheelchair Foam Cushion - 22 x 16 x 3 - 00092237604212 Catalog Number :

Device Description : Wheelchair Foam Cushion - 22 x 16 x 3

Device Class : 1

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

Wheelchair Foam Cushion - 22 x 18 x 3 - 00092237604229 Catalog Number :

Device Class : 1

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

Wheelchair Foam Cushion - 24 x 18 x 3 - 00092237604236 Catalog Number :

Device Class : 1

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

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