DEVICE: PermaLife (10816203023404)
Device Identifier (DI) Information
PermaLife
PL1000P-2G
In Commercial Distribution
PL1000P-2G
ORIGEN BIOMEDICAL, INC.
PL1000P-2G
In Commercial Distribution
PL1000P-2G
ORIGEN BIOMEDICAL, INC.
PermaLife Cell Culture Bag, 1000ml, "P" Set, packed with additional spike port - no green vent cap
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.
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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
b0bc4e7a-a624-4c53-947c-79753df64622
November 13, 2024
4
November 06, 2017
November 13, 2024
4
November 06, 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