DEVICE: PermaLife (10816203023404)

Device Identifier (DI) Information

PermaLife
PL1000P-2G
In Commercial Distribution
PL1000P-2G
ORIGEN BIOMEDICAL, INC.
10816203023404
GS1

1
625272232 *Terms of Use
PermaLife Cell Culture Bag, 1000ml, "P" Set, packed with additional spike port - no green vent cap
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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
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FDA Product Code

[?]
Product Code Product Code Name
LPZ Container, Frozen Donor Tissue Storage
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b0bc4e7a-a624-4c53-947c-79753df64622
November 13, 2024
4
November 06, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1-512-474-7278
regulatory@origenbio.com
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