DEVICE: PVC Transfer Bag (10816203023299)

Device Identifier (DI) Information

PVC Transfer Bag
10-200-CS25
In Commercial Distribution

ORIGEN BIOMEDICAL, INC.
10816203023299
GS1

1
625272232 *Terms of Use
Two 200ml PVC processing bags, with a male luer, a female luer, a needle-free injection port, a spike port, and a CS25 for final freezing of product
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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 washing/centrifugation bag A flexible container intended to be used to facilitate blood processing via blood washing and/or centrifugation (e.g., cryoprecipitation) to achieve separation of blood components [e.g., red blood cells (RBCs), platelets, plasma], typically to generate a blood product from autologous or donor blood for procedural (e.g., surgical haemostasis) or transfusion applications [e.g., fibrinogen rich cryoprecipitate]. It is additionally intended to be used as a blood storage bag, and is made of flexible durable materials that withstand centrifugation and freezing/thawing. This is a single-use device.
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FDA Product Code

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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 [?]
BK140116 0
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ccb10a5d-ac30-4ef4-9b34-14f88fd33757
January 08, 2021
4
June 06, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20816203023296 12 10816203023299 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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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