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) (4) Bed, Flotation Therapy, Powered (IOQ) (2)

Premarket Exempt

Yes

Clear

TheraFlo Cover 54'' × 80'' QLT Sen-1p - 00841965103937 Catalog Number : PR-4001048

Device Description : TheraFlo Cover 54'' × 80'' QLT Sen-1p

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

TheraFlo Cover 60'' × 80'' QLT Sen-1p - 00841965103944 Catalog Number : PR-4001049

Device Description : TheraFlo Cover 60'' × 80'' QLT Sen-1p

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

AiroDyne M-set 36'' × 80'' QLT Burgundy Tridien - 00841965103951 Catalog Number : 3001056

Device Description : AiroDyne M-set 36'' × 80'' QLT Burgundy Tridien

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

AiroDyne M-set 36'' × 84'' QLT Burgundy Tridien - 00841965103968 Catalog Number : 3001063

Device Description : AiroDyne M-set 36'' × 84'' QLT Burgundy Tridien

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

AiroDyne P.U. US Tridien - 00841965103975 Catalog Number : 2001040

Device Description : AiroDyne P.U. US Tridien

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

Reactive Air P.U. W/Tube Tridien US - 00841965103982 Catalog Number : 2001039

Device Description : Reactive Air P.U. W/Tube Tridien US

Device Class : 2

Duns Number: 625060962

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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