DEVICE: Cryostore (10816203020373)

Device Identifier (DI) Information

Cryostore
CS500NS
In Commercial Distribution

ORIGEN BIOMEDICAL, INC.
10816203020373
GS1

1
625272232 *Terms of Use
Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "N" Tubing Set, double aseptic pouched, case of 12
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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 durable, sterile plastic container with ports, or glass bottle, 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. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. 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 [?]
BK030036 0
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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

de48cf8e-03d3-4cde-856c-cbd217dc2ae9
July 06, 2018
5
September 23, 2016
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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
20816203020370 12 10816203020373 In Commercial Distribution Case
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Secondary DI

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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@origen.com
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