Spectra Optia® 11220

GUDID 35020583112200

Single-Needle Connector

TERUMO BCT, INC.

Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set
Primary Device ID35020583112200
NIH Device Record Key4d529ca2-b973-4b80-9b96-12bf7da98e2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectra Optia®
Version Model Number11220
Catalog Number11220
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS135020583112200 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-11
Device Publish Date2021-06-03

On-Brand Devices [Spectra Optia® ]

05020583610002Spectra Optia® Apheresis System
05020583123205IDL Set
05020583113008BMP Accessory Set
05020583121201Collection Set
05020583103108IDL Set
05020583103009IDL Set
05020583101104Collection Set
05020583101203Collection Set
05020583102200Exchange Set
35020583122209Exchange Sets
35020583112200Single-Needle Connector
05020583122208Exchange Sets
05020583112209Single-Needle Connector

Trademark Results [Spectra Optia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPECTRA OPTIA
SPECTRA OPTIA
78796779 3349916 Live/Registered
TERUMO BCT, INC.
2006-01-23

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