FDA.reportPublic FDA data

NexSite HD Hemodialysis Catheter

Primary DI
05391525640365
Brand
NexSite HD Hemodialysis Catheter
Company
MARVAO MEDICAL DEVICES LIMITED
Model
NEXHD1556002
Catalog number
NEXHD1556002
Device description
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 and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a sterile pouch so that the tray can be delivered to the sterile field
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSDCatheter, Hemodialysis, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSDCatheter, Hemodialysis, ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171571000NexSite HD, Hemodialysis Step Tip Catheter (60cm)Marvao Medical Devices, Ltd.2017-11-30MSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391525640372PackageGS15In Commercial Distribution
05391525640365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391525640372053915256403725391525640372
05391525640365053915256403655391525640365

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, implantableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length60Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5083848490info@marvaomedical.com

Regulatory Flags#

DUNS number
896253098
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391525640617BOSS CSC, Crossing Support Catheter. 3590181503590181502023-04-21
05391525640525BOSS CSC, Crossing Support Catheter. 1800001502023-04-14
05391525640556BOSS CSC, Crossing Support Catheter. 3590181503590181502023-04-14
05391525640563BOSS CSC, Crossing Support Catheter. 1800001502023-04-14
05391525640655BOSS CSC, Crossing Support Catheter. 359018135359081352023-04-14
05391525640716BOSS CSC, Crossing Support Catheter. 3500000902023-04-14
05391525640754BOSS CSC, Crossing Support Catheter. 3500000902023-04-14
05391525640815BOSS CSC, Crossing Support Catheter. 1800000901800000902023-04-14
05391525640853BOSS CSC, Crossing Support Catheter. 1800000902023-04-14
05391525640914BOSS CSC, Crossing Support Catheter. 1800001352023-04-14
05391525640952BOSS CSC, Crossing Support Catheter. 1800001352023-04-14
05391525640044NexSite HD Hemodialysis Catheter NEXHD1553201NEXHD15532012014-09-17
05391525640068NexSite HD Hemodialysis Catheter NEXHD1553601NEXHD15536012014-09-17
05391525640082NexSite HD Hemodialysis CatheterNEXHD1554001NEXHD15540012014-09-17
05391525640105NexSite HD Hemodialysis CatheterNEXHD1555501NEXHD15555012015-01-19
05391525640167NexSite HD Split Tip CatheterNEXHDSP163201NEXHDSP1632012015-04-20
05391525640204NexSite HD Split Tip Hemodialysis CatheterNEXHDSP164001NEXHDSP1640012015-04-20
05391525640228NexSite™ HD Split Tip Hemodialysis Catheter NEXHDSP165501NEXHDSP1655012015-04-20
05391525640440NexSite HD Hemodialysis CatheterNEXHDSY1552701NEXHDSY15527012018-08-27
05391525640006NexSite HD Hemodialysis CatheterNEXHD1552401NEXHD15524012014-09-17

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