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

SYSTEM, SUSPENSION, CELL CULTURE (KJF) (6) Separator, Automated, Blood Cell, Diagnostic (GKT) (3) Separator, automated, blood cell, diagnostic (GKT) (1)

Premarket Exempt

Yes No

Clear

Spectra Optia® - 05020583122208 Catalog Number :

Device Description : Exchange Sets

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583123205 Catalog Number :

Device Description : IDL Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Quantum® - 05020583210127 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories, Cell Expansion Set

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Quantum® - 05020583210202 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Quantum® - 05020583210219 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Quantum® - 05020583210226 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Quantum ® - 05020583210233 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories, Waste Bag 4L, Accessory Set

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Quantum® - 05020583210240 Catalog Number :

Device Description : Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set

Device Class :

Duns Number: 801679200

Premarket Exempt : Yes

Product Code : KJF

Prescription Use : No

Device Count : 1

Rika Plasma Separation Set - 05020583212008 Catalog Number :

Device Description : elabeling.terumobct.com

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Rika Plasma Bottle - 05020583213005 Catalog Number :

Device Description : elabeling.terumobct.com

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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