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 And Plasma, Therapeutic (LKN) (3) Separator, Automated, Blood Cell, Diagnostic (GKT) (2) Separator, automated, blood cell, diagnostic (GKT) (2) Medical device data system (OUG) (1) SYSTEM, SUSPENSION, CELL CULTURE (KJF) (1)

Premarket Exempt

No Yes

Clear

Trima Accel® - 05020583826663 Catalog Number :

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

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® LRS® - 05020583826687 Catalog Number : 82668

Device Description : Disposable Tubing Sets

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583827004 Catalog Number :

Device Description : Disposable Tubing Sets, Trima Accel MultiPlasma Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

COBE® 2991 - 05020583908192 Catalog Number : 90819

Device Description : Blood Cell Processing Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

COBE® 2991 - 05020583909014 Catalog Number : 90901

Device Description : Triple Processing Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

COBE® 2991 - 05020583909045 Catalog Number : 90904

Device Description : Coupler and Double Coupler Adaptor

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

COBE® 2991 - 05020583909120 Catalog Number : 90912

Device Description : Coupler and Double Coupler Adaptor

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

Quantum® - 05020583920002 Catalog Number :

Device Description : Cell Expansion System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE - 05020583940109 Catalog Number :

Device Description : TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACE – Lite

Device Class : 1

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

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