DEVICE: NexSite HD Split TIp Hemodialysis Catheter (05391525640129)

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Device Identifier (DI) Information

NexSite HD Split TIp Hemodialysis Catheter
NEXHDSP162401
NEXHDSP162401
MARVAO MEDICAL DEVICES LTD
05391525640129
GS1
1
The NexSite™ HD, Hemodialysis Split Tip Catheter for long term use is a dual lumen, split 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, 17Fr Introducer / Dilator 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
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Double-lumen haemodialysis catheter, implantable A sterile, 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. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MSD Catheter, Hemodialysis, Implanted
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 24 Centimeter
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Device Status

In Commercial Distribution
April 20, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05391525640136 5 05391525640129 In Commercial Distribution Carton with 5 units
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
5083848490
info@marvaomedical.com
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