Rika Plasma Donation System
GUDID 05020583420007
elabeling.terumobct.com
TERUMO BCT, INC.
Apheresis system| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583420007 [Primary] |
| GS1 | 35020583420008 [Package] Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- BK210635
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
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| 05020583112209 - Spectra Optia® | 2022-09-01 Single-Needle Connector |
| 05020583122208 - Spectra Optia® | 2022-09-01 Exchange Sets |
Trademark Results [Rika Plasma Donation System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RIKA PLASMA DONATION SYSTEM 90788535 not registered Live/Pending |
Terumo BCT, Inc. 2021-06-22 |
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