| Primary Device ID | 05020583001145 |
| NIH Device Record Key | c96ecaf1-34d6-4d7d-b954-91f51d6df3a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reveos® Automated Whole Blood Processing System |
| Version Model Number | 24000 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(877)339-4228 |
| FDAUDIprogram@terumobct.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583001145 [Primary] |
| MYY | Separator, Semi-Automated, Blood Component |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-14 |
| Device Publish Date | 2025-08-06 |
| 05020583001145 - Reveos® Automated Whole Blood Processing System | 2025-08-14Reveos® Automated Whole Blood Processing System |
| 05020583001145 - Reveos® Automated Whole Blood Processing System | 2025-08-14 Reveos® Automated Whole Blood Processing System |
| 55020583260318 - SCD Welding Wafer | 2025-05-22 3-NCC987 SCD Wafer |
| 35020583826503 - Trima Accel | 2023-06-27 Trima Accel® LRS® Platelet, Plasma, Auto RBC Set |
| 05020583910003 - COBE® 2991 | 2023-06-27 Blood Cell Processor |
| 05020583419506 - IMUGARD | 2022-12-01 elabeling.terumobct.com |
| 35020583700315 - Accessory Platelet Bag with Integrated Sampler | 2022-12-01 elabeling.terumobct.com |
| 05020583112209 - Spectra Optia® | 2022-09-01 Single-Needle Connector |
| 05020583122208 - Spectra Optia® | 2022-09-01 Exchange Sets |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REVEOS 85313091 4254682 Live/Registered |
TERUMO BCT, INC. 2011-05-05 |