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

Mattress, Air Flotation, Alternating Pressure (FNM) (4) Nebulizer (Direct Patient Interface) (CAF) (3) Bed, Ac-Powered Adjustable Hospital (FNL) (2) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (1)

Premarket Exempt

No Yes

Clear

Roscoe Medical - 00092237602027 Catalog Number :

Device Description : APP Replacement pad, basic

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602034 Catalog Number :

Device Description : Alternating pressure pump and pad

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602041 Catalog Number :

Device Description : Non adjustable Alternating

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602058 Catalog Number :

Device Description : APP replacement pad, deluxe

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602119 Catalog Number :

Device Description : Full Electric Bed 36 x80

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237602171 Catalog Number :

Device Description : 42 Full Electric Bariatric

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237603116 Catalog Number :

Device Description : 00092237603116

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603161 Catalog Number :

Device Description : Roscoe Mini Neb Compressor and

Device Class :

Duns Number: 022542271

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603185 Catalog Number :

Device Description : Roscoe Mini Neb w/ TruNeb Reus

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237603291 Catalog Number :

Device Description : Roscoe Heavy-Duty Aspirator

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : JCX

Prescription Use : Yes

Device Count : 1

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