Primary Device ID | 35020583826169 |
NIH Device Record Key | b1431603-9822-495e-9126-22ec479074a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Trima Accel |
Version Model Number | 82616 |
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 | false |
OTC Over-The-Counter | false |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com | |
Phone | +1(303)205-2510 |
FDAUDIprogram@terumobct.com |
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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05020583826168 [Unit of Use] |
GS1 | 35020583826169 [Primary] |
GKT | Separator, automated, blood cell, diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-02-15 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TRIMA ACCEL 86536259 4858112 Live/Registered |
TERUMO BCT, INC. 2015-02-16 |
![]() TRIMA ACCEL 86536140 4826324 Live/Registered |
TERUMO BCT, INC. 2015-02-16 |
![]() TRIMA ACCEL 78123897 2792993 Dead/Cancelled |
TERUMO BCT, INC. 2002-04-24 |
![]() TRIMA ACCEL 78123888 2796125 Dead/Cancelled |
TERUMO BCT, INC. 2002-04-24 |