Primary Device ID | 05020583420007 |
NIH Device Record Key | a69f6807-0adb-4844-8b91-62fdf82b8498 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rika Plasma Donation System |
Version Model Number | 42000 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Fragile (Box Level) |
Handling Environment Atmospheric Pressure | Between 54.8 KiloPascal and 108.4 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry (Box Level) |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05020583420007 [Primary] |
GS1 | 35020583420008 [Package] Package: [1 Units] In Commercial Distribution |
GKT | Separator, Automated, Blood Cell, Diagnostic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-21 |
Device Publish Date | 2022-07-13 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RIKA PLASMA DONATION SYSTEM 90788535 not registered Live/Pending |
Terumo BCT, Inc. 2021-06-22 |