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

Device, Transfer, Patient, Manual (FMR) (6) Adaptor, Hygiene (ILS) (4)

Premarket Exempt

No Yes

Clear

Geri-Air/ GAP - 00845699000418 Catalog Number :

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Sapphire Comfort Turn Blower - 00845699000425 Catalog Number :

Device Description : 120V Sapphire Comfort Turn Blower Rev. 1 and 2

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Sapphire Pulse Blower - 00845699000432 Catalog Number :

Device Description : 120V Sapphire Pulse Blower Rev 3

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Sapphire 1100 Blower 35" - 00845699000449 Catalog Number :

Device Description : 120V Sapphire 1100 Blower Rev 1 and Rev 2

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Sapphire 1100 Blower EC - 00845699000456 Catalog Number :

Device Description : 120 v Sapphire 1100 Blower EC Rev 3

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Shuttle Series B - Advanced - 00845699000463 Catalog Number :

Device Description : Shuttle Series B

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : FMR

Prescription Use : No

Device Count : 1

Shower Commode 26 - 00845699000470 Catalog Number :

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : ILS

Prescription Use : No

Device Count : 1

Shower Commode 30 - 00845699000494 Catalog Number :

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : ILS

Prescription Use : No

Device Count : 1

Drop Arm Commode 22 (20) - 00845699000500 Catalog Number :

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : ILS

Prescription Use : No

Device Count : 1

Drop Arm Commode 24 - 00845699000517 Catalog Number :

Device Class : 1

Duns Number: 967025602

Premarket Exempt : Yes

Product Code : ILS

Prescription Use : No

Device Count : 1

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