Primary Device ID | 05020583122208 |
NIH Device Record Key | b9498bdb-2e74-4bde-9ce9-b226ff007728 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spectra Optia® |
Version Model Number | 12220 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05020583122208 [Primary] |
GS1 | 35020583122209 [Package] Package: [6 Units] In Commercial Distribution |
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 | 2022-09-01 |
Device Publish Date | 2021-06-03 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPECTRA OPTIA 78796779 3349916 Live/Registered |
TERUMO BCT, INC. 2006-01-23 |