COBE® Spectra 70700

GUDID 35020583707000

Red Blood Cell Exchange Set

TERUMO BCT, INC.

Blood transfer set
Primary Device ID35020583707000
NIH Device Record Keydc4ac7b1-9e0f-4df9-a59d-c477ad819f65
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOBE® Spectra
Version Model Number70700
Catalog Number70700
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com
Phone1 877-339-4228
EmailFDAUDIprogram@terumobct.com

Device Identifiers

Device Issuing AgencyDevice ID
GS135020583707000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

On-Brand Devices [COBE® Spectra ]

05020583719002Refurbished COBE® Spectra Apheresis System
05020583711006Single Needle Set
05020583706200White Blood Cell Set- Functionally Closed
05020583703001Single-Needle Extended Life Platelet Set With LRS® Chamber
05020583706309Bone Marrow Processing Set
05020583706293White Blood Cell-Functionally Closed Tubing
05020583706101Auto PBSC Set
05020583704008Single-Needle Extended Life Platelet Set With LRS® Chamber
05020583701007Dual- Needle Extended Life Platelet Set
05020583700109Single Needle Set
05020583706002COBE Spectra White Blood Cell Set
35020583707000Red Blood Cell Exchange Set
35020583705006Therapeutic Plasma Exchange Set
05020583707009Red Blood Cell Exchange Set
05020583705005Therapeutic Plasma Exchange Set

Trademark Results [COBE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COBE
COBE
87669676 not registered Live/Pending
Cobe ApS
2017-11-02
COBE
COBE
87179606 5520203 Live/Registered
Patrick Campbell
2016-09-22
COBE
COBE
86944902 not registered Live/Pending
Continental Automotive GmbH
2016-03-18
COBE
COBE
86785532 5115656 Live/Registered
Jernudd, Judith G.
2015-10-12
COBE
COBE
75908192 not registered Dead/Abandoned
NET-TEL CORPORATION
2000-02-03
COBE
COBE
75018235 2131032 Live/Registered
TERUMO BCT, INC.
1995-11-13
COBE
COBE
74599256 1974362 Dead/Cancelled
GAMBRO, INC.
1994-11-15
COBE
COBE
73725669 1515251 Live/Registered
COBE LABORATORIES, INC.
1988-05-02
COBE
COBE
73181319 1128505 Dead/Cancelled
COBE LABORATORIES, INC.
1978-08-07
COBE
COBE
72403054 0976436 Dead/Expired
COBE LABORATORIES, INC.
1971-09-20
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