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

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (10)

Premarket Exempt

No Yes

Clear

HARVEST® - 05020583514720 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514744 Catalog Number :

Device Description : SmartPRep® 2 Centrifuge System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514751 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514782 Catalog Number :

Device Description : SmartPrep® 2 Centrifuge System, Two place rotor

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514805 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514829 Catalog Number :

Device Description : SmartPrep® 2 Centrifuge System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514836 Catalog Number :

Device Description : SmartPrep® 2 Centrifuge System

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514867 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System, WS-2 Work Station 2 Cart

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514874 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System, Rolling Cart 2

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514881 Catalog Number :

Device Description : SmartPrep® 3 Multi-Cellular Processing System, Balance Weight PRP 20 BMAC® BW-20

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

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