SyvekExcel Vascular Access Hemostasis System

Basic Information

• Brand Name: SyvekExcel Vascular Access Hemostasis System
• Primary DI: 00389142000056
• Version / Model: 400-16-05
• Catalog Number: 400-16-05
• Company Name: MARINE POLYMER TECHNOLOGIES, INC.
• Labeler DUNS: 809739386
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-05
• Public Version: 7
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: 74c3931f-456e-4313-a997-21f1bde11b39
• Distribution End Date: 2018-11-06

Device Description

SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable handle, 5 alcohol prep pads, 5 caps, 5 tegaderm and 5 Syvek Excel Patches. 4 kits are packaged in one case and sold as a unit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61345	Arterial/central venous catheterization support/maintenance kit, non-medicated	A collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10389142000053	GS1	Case	4	Not in Commercial Distribution	2018-11-06
Primary	00389142000056	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K053300	000