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Syvek Excel Vascular Access Hemostasis Kit

FDA UDI

Class II (US FDA UDI)

by Marine Polymer Technologies, Inc.

Identity

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

Identifiers

Primary DI / UDI-DI
00389142000155 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular catheterization support/maintenance kit, non-medicated

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

Similar devices

Also classified as Vascular catheterization support/maintenance kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Marine Polymer Technologies, Inc.

Sources (1)

  • FDA UDI e9e565e7-1d11-4df7-bc28-ac67d60e7423 35 fields · synced Jun 6, 2026