FDA.reportPublic FDA data

Quantum®

Primary DI
05020583210219
Brand
Quantum®
Company
TERUMO BCT, INC.
Model
21021
Device description
Quantum System Cell Expansion Set and Accessories, Media Bag 4 L, Accessory Set
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJFSYSTEM, SUSPENSION, CELL CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJFSystem, Suspension, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35020583210210PackageGS14In Commercial Distribution
05020583210219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3502058321021035020583210210
05020583210219050205832102195020583210219

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight.
Special Storage Condition, Specify00Protect from rain
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)339-4228FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
801679200
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05020583103108Spectra Optia®103102016-09-15
05020583610002Spectra Optia®610002016-09-15
05020583001145Reveos® Automated Whole Blood Processing System240002025-08-06
05020583826502Trima Accel826502023-06-19
05020583803664Trima Accel® 803662017-02-15
05020583804005Trima Accel®804002016-09-15
05020583824089Trima Accel® 824082016-09-15
05020583826601Trima Accel® 826602016-09-15
05020583826663Trima Accel® 826662017-02-15
05020583700512Blood Component Sampling Sets700512016-09-15
05020583803565Trima Accel® 803562017-02-15
05020583804401Trima Accel® 804402016-09-15
05020583824409Trima Accel® 824402016-09-15
05020583803503Trima Accel® 803502016-09-15
05020583803701Trima Accel® 803702016-09-15
05020583803404Trima Accel® 803402016-09-15
05020583803602Trima Accel® 803602016-09-15
05020583807006Trima Accel® 807002016-09-15
05020583804500Trima Accel® 804502016-09-15
05020583805002Trima Accel® 805002016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850019717471G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717518G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717648G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717488G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717525G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717655G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717624G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717631G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717563G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717570G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717600G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717617G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717587G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-13
00850019717495G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717532G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717501G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717549G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00854498007986Save-A-ToothSmarthealth, Inc.KJF2023-04-03
00850019717457G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717464G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717556G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-09
00850019717419G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717426G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717174G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717181G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717280G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717297G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717150G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717396G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717167G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12