Trima Accel

GUDID 35020583804068

Trima Accel® LRS® Platelet, Plasma, RBC Set

TERUMO BCT, INC.

Blood transfer set Blood transfer set

• Primary Device ID: 35020583804068
• NIH Device Record Key: 86fbf57e-7f0f-49cf-8b7a-e75022b0fa51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trima Accel
• Version Model Number: 80406
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583804067 [Unit of Use]
GS1	35020583804068 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-15

On-Brand Devices [Trima Accel]

• 35020583826664: Trima Accel® LRS Platelet + Sampler, Plasma, Auto RBC Set
• 35020583826565: Trima Accel® LRS Platelet, Plasma, Auto RBC Set
• 35020583826169: Trima Accel® LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set
• 35020583824462: Trima Accel® LRS Platelet + Sampler, Plasma, RBC Set
• 35020583824165: Trima Accel® LRS Platelet + 35 mL Sampler, Multi Plasma, RBC Set
• 35020583824066: Trima Accel® LRS® Platelet, Plasma, RBC Set
• 35020583804464: Trima Accel® LRS Platelet + Sampler, Plasma, RBC Set
• 35020583804068: Trima Accel® LRS® Platelet, Plasma, RBC Set
• 35020583803665: Trima Accel® Platelet + Sampler, Plasma, Auto RBC Set
• 35020583803566: Trima Accel® Platelet, Plasma, Auto RBC Set
• 05020583826564: Trima Accel® LRS®Platelet, Plasma, Auto RBC Set
• 35020583826503: Trima Accel® LRS® Platelet, Plasma, Auto RBC Set