| Primary Device ID | 35020583113009 |
| NIH Device Record Key | d23a379a-8355-48d6-a2ee-6e0b43a4c8dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectra Optia BMP Set w/Source Plasma Bag |
| Version Model Number | 11300 |
| 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 |
| Phone | +1(303)205-2510 |
| FDAUDIprogram@terumobct.com | |
| Phone | +1(303)205-2510 |
| FDAUDIprogram@terumobct.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 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 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583113008 [Unit of Use] |
| GS1 | 35020583113009 [Primary] |
| PKG | Bone marrow processing device to support hematopoietic reconstitution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-15 |
| 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 |
| 05020583700703 - Platelet Additive Solution Connection Adapter | 2022-09-01 PLATELET ADDITIVE SOLUTION CONNECTION ADAPTER |
| 05020583705005 - COBE® Spectra | 2022-09-01 Therapeutic Plasma Exchange Set |