DEVICE: PermaLife (10816203023244)
Device Identifier (DI) Information
PermaLife
PL120N
In Commercial Distribution
PL120N
ORIGEN BIOMEDICAL, INC.
PL120N
In Commercial Distribution
PL120N
ORIGEN BIOMEDICAL, INC.
PermaLife Cell Culture Bag, 120ml, with SCD Tubing
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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 |
---|---|
LPZ | Container, Frozen Donor Tissue Storage |
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 Dry |
Special Storage Condition, Specify: Do not re-use |
Special Storage Condition, Specify: Do not use if package is damaged |
Special Storage Condition, Specify: Do not resterilize |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
17669d9b-fd0a-4f33-af41-d1d1ad602dbb
November 13, 2024
4
May 19, 2017
November 13, 2024
4
May 19, 2017
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
[?]
+1-512-474-7278
regulatory@origenbio.com
regulatory@origenbio.com