DEVICE: NexSite HD Hemodialysis Catheter (05391525640006)
Device Identifier (DI) Information
NexSite HD Hemodialysis Catheter
NEXHD1552401
In Commercial Distribution
NEXHD1552401
MARVAO MEDICAL DEVICES LIMITED
NEXHD1552401
In Commercial Distribution
NEXHD1552401
MARVAO MEDICAL DEVICES LIMITED
The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038” guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator, Coring Scalpel and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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37278 | Double-lumen haemodialysis catheter, implantable |
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
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FDA Product Code
[?]Product Code | Product Code Name |
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MSD | Catheter, Hemodialysis, Implanted |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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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Length: 24 Centimeter |
Device Record Status
808cf602-6d24-46c1-9b9a-20499a75763f
February 05, 2021
4
September 17, 2014
February 05, 2021
4
September 17, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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05391525640013 | 5 | 05391525640006 | In Commercial Distribution | Carton with 5 units |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
5083848490
info@marvaomedical.com
info@marvaomedical.com