Syvek Excel Vascular Access Hemostasis Kit

Basic Information

• Brand Name: Syvek Excel Vascular Access Hemostasis Kit
• Primary DI: 00389142000155
• Version / Model: 400-16-05
• Company Name: MARINE POLYMER TECHNOLOGIES, INC.
• Labeler DUNS: 809739386
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-17
• Public Version: 3
• Public Version Date: 2020-10-06
• Public Version Status: Update
• Public Device Record Key: e9e565e7-1d11-4df7-bc28-ac67d60e7423

Device Description

The Syvek Excel Vascular Access Hemostasis kit contains 2 boxes of 10 handles, 10 caps and 10 alcohol prep pads each and (1) sleeve of Excel Patches (UDI 20389142000067) which contains 20 Excel Patches (UDI 00389142000063) with 20 Tegaderm The pieces are consumed together (1) handle, (1) cap, (1) alcohol prep pad, (1) Tegaderm and (1) Syvek Excel Patch.

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
Primary	00389142000155	GS1
Previous	00389142000056	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053300	000