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) (7) Bed, Flotation Therapy, Powered (IOQ) (3)

Premarket Exempt

Yes

Clear

SenTech - 00841965100653 Catalog Number : 12-SM50-R

Device Description : Sentry 1250 Controller, Rebran

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100660 Catalog Number : 12SM-EUHV-KIT

Device Description : Controller Kit,230/50Hz,EU,SR

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100677 Catalog Number : 12SM-SALV-KIT

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Stryker Air - 00841965100684 Catalog Number : 60SM-3000

Device Description : LowVoltage,International,Contr

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

IsoAir - 00841965100691 Catalog Number : 12SM-SRHV-E

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Stryker Air - 00841965100707 Catalog Number : 60SM-4000

Device Description : HV,Intl,System,Contrl, IT

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

IsoAir - 00841965100714 Catalog Number : 12SM-SRHV-G

Device Description : Assy,Syst,Contr,IsoAir, UK, Ir

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Stryker Air - 00841965100721 Catalog Number : 60SM-4001

Device Description : HV,Intl,System,Contrl, D

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

IsoAir - 00841965100745 Catalog Number : 12SM-SRHV-I

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

IsoAir - 00841965100752 Catalog Number : 12SM-SRHV-J

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

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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