Blood Component Sampling Sets

GUDID 05020583700512

Blood Component Sampling Sets

TERUMO BCT, INC.

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Primary Device ID05020583700512
NIH Device Record Key7f78059a-f433-4a9b-85cb-a9ee29fe3e73
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Component Sampling Sets
Version Model Number70051
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exempttrue
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

Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583700512 [Primary]
GS135020583700513 [Package]
Package: [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-12-16
Device Publish Date2016-09-15

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05020583705005 - COBE® Spectra 2022-09-01 Therapeutic Plasma Exchange Set

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