DEVICE: Spike Adapter (10816203020588)
Device Identifier (DI) Information
Spike Adapter
150-S-M
Not in Commercial Distribution
ORIGEN BIOMEDICAL, INC.
150-S-M
Not in Commercial Distribution
ORIGEN BIOMEDICAL, INC.
One spike to one male luer with 150cm tubing and roller clamp
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? |
---|---|---|---|---|
43324 | Fluid transfer set, general-purpose |
A collection of 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 not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
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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 |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
208c42f3-2345-4a07-8154-709033d19ac4
April 23, 2024
4
September 23, 2016
April 23, 2024
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20816203020585 | 20 | 10816203020588 | 2024-04-22 | Not in Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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