Spectra Optia Collection Set

GUDID 35020583101105

Optia Collections Set (MNC2)

TERUMO BCT, INC.

Blood transfer set Blood transfer set

• Primary Device ID: 35020583101105
• NIH Device Record Key: b20d2cb9-ea51-4abc-b563-f65d455a5e4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra Optia Collection Set
• Version Model Number: 10110
• 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

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583101104 [Unit of Use]
GS1	35020583101105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120012

FDA Product Code

• GKT: Separator, automated, blood cell, diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Spectra Optia Collection Set]

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