Quantum Cell Expansion Set

GUDID 35020583210128

Cell Expansion Set Type 1 - 004203-0041

TERUMO BCT, INC.

Blood/tissue storage/culture container
Primary Device ID35020583210128
NIH Device Record Keyea9a08a1-32e5-4d30-9ad2-93dd8d076af8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Cell Expansion Set
Version Model Number21012
Company DUNS801679200
Company NameTERUMO BCT, INC.
Device Count2
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(303)205-2510
EmailFDAUDIprogram@terumobct.com
Phone+1(303)205-2510
EmailFDAUDIprogram@terumobct.com

Operating and Storage Conditions

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 [Unit of Use]
GS135020583210128 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

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