Tridien 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) (10)

Premarket Exempt

Yes

Clear

IsoAir - 00841965103630 Catalog Number : SYS-SR-011

Device Description : Sys,SR,Saudi,IR,35x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103647 Catalog Number : SYS-SR-012

Device Description : Sys,SR,Saudi,IR,32x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103654 Catalog Number : SYS-SR-013

Device Description : Sys,SR,Saudi,IR,35x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103661 Catalog Number : SYS-SR-014

Device Description : Sys,SR,Saudi,IR,32x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103678 Catalog Number : SYS-SR-015

Device Description : Sys,SR,Aust,35x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103685 Catalog Number : SYS-SR-016

Device Description : Sys,SR,Aust,32x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103692 Catalog Number : SYS-SR-017

Device Description : Sys,SR,Aust,35x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103708 Catalog Number : SYS-SR-018

Device Description : Sys,SR,Aust,32x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103715 Catalog Number : SYS-SR-019

Device Description : Sys,SR,Switzer,35x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103722 Catalog Number : SYS-SR-020

Device Description : Sys,SR,Switzer,32x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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