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

SenTech - 00841965103531 Catalog Number : 77-SM22MAC

Device Description : MobileAirChair OverlayCoverlet

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103548 Catalog Number : SYS-SR-001

Device Description : Sys,SR,CAN,35x84x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103555 Catalog Number : SYS-SR-003

Device Description : Sys,SR,Bel,FR,Pol,35x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103562 Catalog Number : SYS-SR-004

Device Description : Sys,SR,Bel,FR,Pol,32x80x5.5"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103579 Catalog Number : SYS-SR-005

Device Description : Sys,SR,Bel,FR,Pol,35x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103586 Catalog Number : SYS-SR-006

Device Description : Sys,SR,Bel,FR,Pol,32x80x8"

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103593 Catalog Number : SYS-SR-007

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103609 Catalog Number : SYS-SR-008

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103616 Catalog Number : SYS-SR-009

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965103623 Catalog Number : SYS-SR-010

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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