Tridien Medical

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) (9) Bed, Flotation Therapy, Powered (IOQ) (1)

Premarket Exempt

Yes

Clear

IsoAir - 00841965100486 Catalog Number : 45A-SR5-3584

Device Description : Mattress, 35X84, 5.5', SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100493 Catalog Number : 45A-SR5-3280

Device Description : Mattress, 32x80, 5.5", SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100509 Catalog Number : 45A-SR5-3580

Device Description : Mattress, 35X80, 5.5', SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100516 Catalog Number : 45A-SR8-3280

Device Description : Mattress, 32x80, 8", SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100523 Catalog Number : 45A-SR8-3580

Device Description : Mattress, 35x80, 8", SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

SenTech - 00841965100554 Catalog Number : 77-SM22BAC-B

Device Description : BedsideAirChairOverlay/Cover

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Stryker Air - 00841965100592 Catalog Number : 60SM-2000

Device Description : Low Voltage, US, Controller

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

IsoAir - 00841965100608 Catalog Number : 12SM-SRLV-BH

Device Description : Assy,Syst,Contr,IsoAir, USA

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100615 Catalog Number : 12SM-USLV-KIT

Device Description : Controller Kit, 120/60Hz US, SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100622 Catalog Number : SYS-SR-002

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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