DEVICE: Quantum® (05020583920002)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44904 | Blood/tissue storage/culture container |
A receptacle 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. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KJF | SYSTEM, SUSPENSION, CELL CULTURE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep out of sunlight. |
Special Storage Condition, Specify: Protect from rain |
Storage Environment Temperature: between 2 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
06e893d2-81ca-4563-b2a5-f0e00d723330
July 24, 2023
7
September 15, 2016
July 24, 2023
7
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)339-4228
FDAUDIprogram@terumobct.com
FDAUDIprogram@terumobct.com