DEVICE: Accessories (10816203023442)
Device Identifier (DI) Information
Accessories
15-R6F-TA
In Commercial Distribution
15-R6F-TA
ORIGEN BIOMEDICAL, INC.
15-R6F-TA
In Commercial Distribution
15-R6F-TA
ORIGEN BIOMEDICAL, INC.
6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KJG | Tube, Tissue Culture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
28d08396-1466-419e-beec-82b6b54e7f17
December 16, 2024
1
December 06, 2024
December 16, 2024
1
December 06, 2024
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-512-474-7278
regulatory@origenbio.com
regulatory@origenbio.com