DEVICE: CryoStore (10816203023572)

Device Identifier (DI) Information

CryoStore
CS20NS
In Commercial Distribution
CS20NS
ORIGEN BIOMEDICAL, INC.
10816203023572
GS1

1
625272232 *Terms of Use
CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "NS" Tube Set
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK180278 0
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

87dfb48a-7023-43b9-ba18-ea7c4139bd23
June 17, 2022
2
November 15, 2021
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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
20816203023579 12 10816203023572 In Commercial Distribution Case
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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

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