Spectra Optia®

GUDID 05020583122208

Exchange Sets

TERUMO BCT, INC.

Blood transfer set
Primary Device ID05020583122208
NIH Device Record Keyb9498bdb-2e74-4bde-9ce9-b226ff007728
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectra Optia®
Version Model Number12220
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 Datefalse
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
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583122208 [Primary]
GS135020583122209 [Package]
Package: [6 Units]
In Commercial Distribution

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-09-01
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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