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

SET, TRANSFER (BLOOD/PLASMA) (KSB) (5) SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS (MMH) (3) Separator, Automated, Blood Cell, Diagnostic (GKT) (1) Separator, automated, blood cell, diagnostic (GKT) (1)

Premarket Exempt

No Yes

Clear

Vista ® - 05020583252011 Catalog Number :

Device Description : Vista Information System, Version 4.2

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Vista® - 05020583252028 Catalog Number :

Device Description : Information System Version 4, Vista Standard Interface and SafeTrace®BBSI Instal Information System Version 4, Vista Standard Interface and SafeTrace®BBSI Installation Guide

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

Vista ® - 05020583252035 Catalog Number :

Device Description : Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MMH

Prescription Use : Yes

Device Count : 1

SCD® IIB - 05020583300026 Catalog Number :

Device Description : SCD II Final Assembly

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

TSCD® II - 05020583300033 Catalog Number :

Device Description : Sterile Tubing Welder

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

TSCD® - 05020583300040 Catalog Number :

Device Description : Weld Integrity Test Kit

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

TSCD®-II - 05020583300064 Catalog Number :

Device Description : 3-Ncc947 Weld Integrity Test Kit

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Trucise® 2.0 Total System - 05020583300088 Catalog Number :

Device Description : Trucise 2.0 Communication Module

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : KSB

Prescription Use : Yes

Device Count : 1

Trima Accel® - 05020583300132 Catalog Number :

Device Description : Seal Safe, Trima, Rohs

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Rika Plasma Donation System - 05020583420007 Catalog Number :

Device Description : elabeling.terumobct.com

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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