Trima

GUDID 35020583803702

Trima Accel Platelet + Sampler + Auto PAS, MultiPlasma, RBC Set

TERUMO BCT, INC.

Blood transfer set

• Primary Device ID: 35020583803702
• NIH Device Record Key: ceaad03f-a47b-4bc7-a0ab-3d439f51202c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trima
• Version Model Number: 80370
• 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 *Keep out of sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from rain

Device Identifiers

Device Issuing Agency	Device ID
GS1	05020583803701 [Unit of Use]
GS1	35020583803702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120049

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 [Trima]

• 35020583827005: Trima Accel MultiPlasma Set
• 35020583826602: Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
• 35020583825605: Trima Accel Platelet, Plasma, Auto RBC Set
• 35020583825209: Trima Accel Auto RBC, Plasma Set
• 35020583825001: Trima Accel RBC, Plasma Set
• 35020583824707: Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set
• 35020583824400: Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
• 35020583824103: Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set
• 35020583824080: Trima Accel Platelet + Sampler, MultiPlasma RBC Set
• 35020583824004: Trima Accel LRS Platelet, Plasma, RBC Set
• 35020583823007: Trima Accel LRS Platelet, Plasma Set
• 35020583807007: Trima Accel MultiPlasma Set (ISBT)
• 35020583805508: Trima Accel RBC + TLR Filter, Plasma Set (ISBT)
• 35020583805201: Trima Accel Auto RBC, Plasma Set (ISBT)
• 35020583805003: Trima Accel RBC, Plasma Set (ISBT)
• 35020583804501: Trima Accel Plt, Pls, RBC w/ Filter ISBT
• 35020583804402: Trima Accel Platelet + Sampler, Plasma, RBC Set (ISBT)
• 35020583804105: Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set (ISBT)
• 35020583804006: Trima Accel LRS Platelet, Plasma, RBC Set (ISBT)
• 35020583803702: Trima Accel Platelet + Sampler + Auto PAS, MultiPlasma, RBC Set
• 35020583803603: Trima Accel Platelet + Sampler, Plasma, Auto RBC Set (ISBT)
• 35020583803504: Trima Accel Platelet, Plasma, Auto RBC Set (ISBT)
• 35020583803405: Trima Accel Platelet + Sampler, MultiPlasma RBC Set (ISBT)
• 35020583803009: Trima Accel LRS Platelet, Plasma Set (ISBT)