DEVICE: Accessories (10816203023442)

Device Identifier (DI) Information

Accessories
15-R6F-TA
In Commercial Distribution
15-R6F-TA
ORIGEN BIOMEDICAL, INC.
10816203023442
GS1

1
625272232 *Terms of Use
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
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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?
44903 Blood transfer set
A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KJG Tube, Tissue Culture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

28d08396-1466-419e-beec-82b6b54e7f17
December 16, 2024
1
December 06, 2024
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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
20816203023449 25 10816203023442 In Commercial Distribution Carton
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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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