Quantum ®
GUDID 05020583210233
Quantum System Cell Expansion Set and Accessories, Waste Bag 4L, Accessory Set
TERUMO BCT, INC.
Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container| Primary Device ID | 05020583210233 |
| NIH Device Record Key | 2af0a794-7369-490a-9263-2ade2167a598 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum ® |
| Version Model Number | 21023 |
| Company DUNS | 801679200 |
| Company Name | TERUMO BCT, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 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 2 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583210233 [Primary] |
| GS1 | 35020583210234 [Package] Package: [10 Units] In Commercial Distribution |
FDA Product Code
| KJF | SYSTEM, SUSPENSION, CELL CULTURE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-12-16 |
| Device Publish Date | 2016-09-15 |
Devices Manufactured by TERUMO BCT, INC.
| 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 |
Trademark Results [Quantum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
 QUANTUM 98276061 not registered Live/Pending |
Jayakumar, Philip 2023-11-17 |
 QUANTUM 98268023 not registered Live/Pending |
CREATIVE SYSTEMS AND DESIGN, LLC 2023-11-13 |
 QUANTUM 98264792 not registered Live/Pending |
PPG INDUSTRIES OHIO, INC. 2023-11-10 |
 QUANTUM 98251741 not registered Live/Pending |
SOILSON, JEFFREY A. 2023-11-02 |
 QUANTUM 98239151 not registered Live/Pending |
GEA Farm Technologies, Inc. 2023-10-25 |
 QUANTUM 98238680 not registered Live/Pending |
Cozzia USA, LLC 2023-10-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.