SyvekExcel Vascular Access Hemostasis System

FDA UDI

Class II (US FDA UDI)

by Marine Polymer Technologies, Inc.

Identity

Trade Name: SyvekExcel Vascular Access Hemostasis System FDA UDI
Generic Name: Vascular catheterization support/maintenance kit, non-medicated FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 400-16-05 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 400-16-05 FDA UDI
Primary DI / UDI-DI: 00389142000056 FDA UDI
510(k) Number: K053300 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Vascular catheterization support/maintenance kit, non-medicated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

SyvekExcel Vascular Access Hemostasis System by Marine Polymer Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K053300 also covers:

Syvek Excel Vascular Access Hemostasis Kit — MARINE POLYMER TECHNOLOGIES, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Marine Polymer Technologies, Inc.

Sources (1)

FDA UDI 74c3931f-456e-4313-a997-21f1bde11b39 37 fields · synced Jun 8, 2026