DEVICE: Accessories (10816203023435)
Device Identifier (DI) Information
Accessories
40-PF-2M
In Commercial Distribution
ORIGEN BIOMEDICAL, INC.
40-PF-2M
In Commercial Distribution
ORIGEN BIOMEDICAL, INC.
Two male luers to one spike port and one female luer with 20cm SCD tubing with pinch clamps.
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 |
---|---|
Fluid transfer set, general-purpose | A collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8fbf45a4-4ab7-407e-9afe-fd76cd0a67d7
September 14, 2018
1
August 14, 2018
September 14, 2018
1
August 14, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20816203023432 | 12 | 10816203023435 | In Commercial Distribution | pouch |
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
[?]
512-474-7278
regulatory@origen.com
regulatory@origen.com