Spectra Optia IDL Set

GUDID 35020583103000

Blood transfer set

Primary Device ID	35020583103000
NIH Device Record Key	3d356733-3144-4584-82dd-26a1afb46d85
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spectra Optia IDL Set
Version Model Number	10300
Company DUNS	801679200
Company Name	TERUMO BCT, INC.
Device Count	6
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	+1(303)205-2510
Email	FDAUDIprogram@terumobct.com
Phone	+1(303)205-2510
Email	FDAUDIprogram@terumobct.com

Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from rain
Special Storage Condition, Specify	Between 0 and 0 *Keep out of sunlight.
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Protect from rain
Special Storage Condition, Specify	Between 0 and 0 *Keep out of sunlight.

Device Issuing Agency	Device ID
GS1	05020583103009 [Unit of Use]
GS1	35020583103000 [Primary]

GKT	Separator, automated, blood cell, diagnostic

Steralize Prior To Use	false
Device Is Sterile	true