TERUMO BCT, INC.

Address:10811 W COLLINS AVE,Lakewood,CO,80215,US

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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

Separator, automated, blood cell, diagnostic (GKT) (10)

Premarket Exempt

No Yes

Clear

Trima Accel® - 05020583807006 Catalog Number :

Device Description : MultiPlasma Sets

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583810006 Catalog Number :

Device Description : Automated Blood Collection System

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583810013 Catalog Number :

Device Description : Automated Blood Collection System

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583810020 Catalog Number :

Device Description : Automated Blood Collection System

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583823006 Catalog Number :

Device Description : Disposable Tubing Sets, LRS Platelet, Plasma Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583824003 Catalog Number :

Device Description : Disposable Tubing Sets, LRS® Platelet, Plasma, RBC Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583824065 Catalog Number :

Device Description : Disposable Tubing Sets, Trima Accel® LRS® Platelet, Plasma, RBC Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583824089 Catalog Number :

Device Description : Disposable Tubing Sets, Platelet + Sampler, MultiPlasma RBC Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583824102 Catalog Number :

Device Description : Disposable Tubing Sets, LRS Platelet, Plasma, RBC + Auto PAS Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583824164 Catalog Number :

Device Description : Disposable Tubing Sets, LRS Platelet + 35 mL Sampler, Multi Plasma, RBC Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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