SIZEWISE RENTALS, L.L.C.

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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) (10)

Premarket Exempt

No Yes

Clear

Static LAL Mattress - 00845699005819 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

8" Replacement Mattress - 00845699005833 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Clinicare Active Mattress w/ Micro Climate Management - 00845699005840 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Clinicare Hybrid 3000 Mattress w/ Micro Climate Management - 00845699005857 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Tom 2 Pediatric Pulse Mattress - 00845699005864 Catalog Number :

Device Description : Pediatric pulse mattress

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

3 Hose 10" Air Mattress - 00845699005871 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Pediatric Pulse LAL Mattress - 00845699005888 Catalog Number :

Device Description : Pediatric Pulse LAL Mattress with gray straps

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Platinum 6000 Crosscare Mattress w/ Hercules Patient Repositioner - 00845699005895 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Platinum 6000 Alliance Mattress - 00845699005901 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Carewise 13.1 Mattress Family - 00845699005918 Catalog Number :

Device Class : 2

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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