Spectra Optia®
GUDID 05020583610002
Spectra Optia® Apheresis System
TERUMO BCT, INC.
Apheresis system| Primary Device ID | 05020583610002 |
| NIH Device Record Key | 6811bcea-6766-4bb8-9750-37c83ef811e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectra Optia® |
| Version Model Number | 61000 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from rain |
| 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 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 0 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583610002 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK140151
FDA Product Code
| GKT | Separator, automated, blood cell, diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Spectra Optia®]
| 05020583610002 | Spectra Optia® Apheresis System |
| 05020583123205 | IDL Set |
| 05020583113008 | BMP Accessory Set |
| 05020583121201 | Collection Set |
| 05020583103108 | IDL Set |
| 05020583103009 | IDL Set |
| 05020583101104 | Collection Set |
| 05020583101203 | Collection Set |
| 05020583102200 | Exchange Set |
| 35020583122209 | Exchange Sets |
| 35020583112200 | Single-Needle Connector |
| 05020583122208 | Exchange Sets |
| 05020583112209 | Single-Needle Connector |
Trademark Results [Spectra Optia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRA OPTIA 78796779 3349916 Live/Registered |
TERUMO BCT, INC. 2006-01-23 |
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