Spectra Optia Collection Set

GUDID 35020583101204

Optia Collections Set (10120)

TERUMO BCT, INC.

Blood transfer set
Primary Device ID35020583101204
NIH Device Record Key745288a8-81a1-4327-b7fb-034dfb3a6533
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectra Optia Collection Set
Version Model Number10120
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count6
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(303)205-2510
EmailFDAUDIprogram@terumobct.com
Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583101203 [Unit of Use]
GS135020583101204 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [Spectra Optia Collection Set]

35020583121202Spectra Optia Collection Set
35020583101204Optia Collections Set (10120)
35020583101105Optia Collections Set (MNC2)

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