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

Pump, Breast, Powered (HGX) (2) Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (2) Bed, Ac-Powered Adjustable Hospital (FNL) (2) Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (IMG) (1) Oximeter, Infrared, Sporting, Aviation (OCH) (1) Conserver, Oxygen (NFB) (1) Mattress, Air Flotation, Alternating Pressure (FNM) (1)

Premarket Exempt

No Yes

Clear

Roscoe Medical - 00092237604595 Catalog Number :

Device Description : Finger Pulse Oximeter, OTC

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : OCH

Prescription Use : Yes

Device Count : 1

N/A - 00092237605462 Catalog Number :

Device Description : ComboCare E-Stim and

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Roscoe Medical - 00092237606827 Catalog Number :

Device Description : Altus Pump Replacement, for

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

N/A - 00092237611623 Catalog Number :

Device Description : Quattro 2.5

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Viverity - 00092237612217 Catalog Number :

Device Description : Single Electric Breast Pump

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Viverity - 00092237612255 Catalog Number :

Device Description : Double Electric Deluxe Breast

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : HGX

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237615270 Catalog Number :

Device Description : Semi Electric Head, Foot Frame and motor

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237615287 Catalog Number :

Device Description : Semi Electric Bed, Head and Footboards

Device Class : 2

Duns Number: 022542271

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

Roscoe Medical - 00092237615751 Catalog Number :

Device Description : Roscoe Single Lumen Conserver,

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : NFB

Prescription Use : Yes

Device Count : 1

N/A - 00092237616437 Catalog Number :

Device Description : 1cm Sound Head - 2nd Gen

Device Class : 2

Duns Number: 022542271

Premarket Exempt : No

Product Code : IMG

Prescription Use : Yes

Device Count : 1

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