DEVICE: DLP® (00673978861579)
Device Identifier (DI) Information
DLP®
CB20112
Not in Commercial Distribution
MEDTRONIC, INC.
CB20112
Not in Commercial Distribution
MEDTRONIC, INC.
CANNULA CB20112 AR VNT LONG 12GA CARM 8L
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
47799 | Cardioplegia cannula |
A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K810548 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 9.0 French |
Device Record Status
25e4eed9-3ef5-4d3a-9344-e257c47cdf2f
July 06, 2018
3
April 29, 2016
July 06, 2018
3
April 29, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com