Quantum®
GUDID 05020583210202
Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set
TERUMO BCT, INC.
Blood/tissue storage/culture container| Primary Device ID | 05020583210202 |
| NIH Device Record Key | 8894d53b-758a-4053-b57a-9e7700c11f50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum® |
| Version Model Number | 21020 |
| 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 *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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05020583210202 [Primary] |
| GS1 | 35020583210203 [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 |
On-Brand Devices [Quantum® ]
| 05020583920002 | Cell Expansion System |
| 05020583210202 | Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set |
| 05020583210127 | Quantum System Cell Expansion Set and Accessories, Cell Expansion Set |
| 05020583210240 | Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set |
| 05020583210226 | Quantum System Cell Expansion Set and Accessories |
| 05020583210219 | Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set |
Trademark Results [Quantum]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.