NexSite HD Hemodialysis Catheter NEXHD1556002

GUDID 05391525640365

The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaque polyurethane catheter which contains a Dacron biomate

MARVAO MEDICAL DEVICES LIMITED

Double-lumen haemodialysis catheter, implantable

• Primary Device ID: 05391525640365
• NIH Device Record Key: 85d126b9-8598-426f-a148-3706c42630b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexSite HD Hemodialysis Catheter
• Version Model Number: NEXHD1556002
• Catalog Number: NEXHD1556002
• Company DUNS: 896253098
• Company Name: MARVAO MEDICAL DEVICES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com
• Phone: 5083848490
• Email: info@marvaomedical.com

Device Dimensions

• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter
• Length: 60 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525640365 [Primary]
GS1	05391525640372 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171571

FDA Product Code

• MSD: Catheter, Hemodialysis, Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-01-05

On-Brand Devices [NexSite HD Hemodialysis Catheter]

• 05391525640501: The NexSite™ HD , Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radio
• 05391525640488: The NexSite™ HD,Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiopa
• 05391525640464: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
• 05391525640457: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
• 05391525640426: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
• 05391525640402: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, symmetric tip radiop
• 05391525640365: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640341: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640327: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640303: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640280: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640266: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640242: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640112: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640099: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640075: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640051: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640020: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq
• 05391525640006: The NexSite™ HD, Hemodialysis Catheter for long term use is a dual lumen, stepped tip radiopaq