TERUMO BCT, INC.

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) (6) Blood Establishment Computer Software And Accessories (MMH) (1) Bone marrow processing device to support hematopoietic reconstitution (PKG) (1) Separator, Automated, Blood Cell And Plasma, Therapeutic (LKN) (1)

Premarket Exempt

No Yes

Clear

Spectra Optia® - 05020583101104 Catalog Number :

Device Description : Collection Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583101203 Catalog Number :

Device Description : Collection Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583102200 Catalog Number : 10220

Device Description : Exchange Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : LKN

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583103009 Catalog Number :

Device Description : IDL Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583103108 Catalog Number :

Device Description : IDL Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583112209 Catalog Number : 11220

Device Description : Single-Needle Connector

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Anticoagulant Connection Adapter - 05020583112216 Catalog Number :

Device Description : Anticoagulant Connection Adapter

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

Spectra Optia® - 05020583113008 Catalog Number :

Device Description : BMP Accessory Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : PKG

Prescription Use : Yes

Device Count : 1

TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE - 05020583114012 Catalog Number : 11401

Device Description : TOMEs Terumo Operational Medical Equipment Software Version 7.3

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MMH

Prescription Use : No

Device Count : 1

Spectra Optia® - 05020583121201 Catalog Number :

Device Description : Collection Set

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : GKT

Prescription Use : Yes

Device Count : 1

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