Quantum®

GUDID 05020583210127

Quantum System Cell Expansion Set and Accessories, Cell Expansion Set

TERUMO BCT, INC.

Blood/tissue storage/culture container
Primary Device ID05020583210127
NIH Device Record Keyea9a08a1-32e5-4d30-9ad2-93dd8d076af8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum®
Version Model Number21012
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com
Phone+1(877)339-4228
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from rain
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS105020583210127 [Primary]
GS135020583210128 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Product Code

KJFSYSTEM, SUSPENSION, CELL CULTURE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-16
Device Publish Date2016-09-15

On-Brand Devices [Quantum® ]

05020583920002Cell Expansion System
05020583210202Quantum System Cell Expansion Set and Accessories, Cell Inlet Bag 0.5 L, Accessory Set
05020583210127Quantum System Cell Expansion Set and Accessories, Cell Expansion Set
05020583210240Quantum System Cell Expansion Set and Accessories, 200 Micron In-Line Filter Accessory Set
05020583210226Quantum System Cell Expansion Set and Accessories
05020583210219Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set

Trademark Results [Quantum]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTUM
QUANTUM
98867628 not registered Live/Pending
Xplorian LLC
2024-11-22
QUANTUM
QUANTUM
98807712 not registered Live/Pending
Into-Me-Sea LLC
2024-10-17
QUANTUM
QUANTUM
98804816 not registered Live/Pending
QuantumADR LLC
2024-10-16
QUANTUM
QUANTUM
98719255 not registered Live/Pending
Evolve Biologix Inc.
2024-08-27
QUANTUM
QUANTUM
98705080 not registered Live/Pending
Intervet Inc.
2024-08-19
QUANTUM
QUANTUM
98650676 not registered Live/Pending
Raynor Marketing Ltd.
2024-07-16
QUANTUM
QUANTUM
98424129 not registered Live/Pending
HOUSE X AMERICA LLC
2024-02-27
QUANTUM
QUANTUM
98417725 not registered Live/Pending
Meta Materials Inc.
2024-02-23
QUANTUM
QUANTUM
98388177 not registered Live/Pending
Thomas P. Dakich
2024-02-02
QUANTUM
QUANTUM
98386723 not registered Live/Pending
Kuku, Jalil
2024-02-01
QUANTUM
QUANTUM
98384415 not registered Live/Pending
Starkey Laboratories, Inc.
2024-01-31
QUANTUM
QUANTUM
98362353 not registered Live/Pending
The Upper Deck Company
2024-01-17

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