Syvek Excel Vascular Access Hemostasis Kit

GUDID 00389142000155

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.

MARINE POLYMER TECHNOLOGIES, INC.

Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated Arterial/central venous catheterization support/maintenance kit, non-medicated
Primary Device ID00389142000155
NIH Device Record Keye9e565e7-1d11-4df7-bc28-ac67d60e7423
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyvek Excel Vascular Access Hemostasis Kit
Version Model Number400-16-05
Company DUNS809739386
Company NameMARINE POLYMER TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com
Phone1-888-666-2560
Emailpattid@webmpt.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100389142000056 [Previous]
GS100389142000155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-12-17

Devices Manufactured by MARINE POLYMER TECHNOLOGIES, INC.

10389142000039 - Syvek Brace with Straps2020-10-30 Syvek Brace with Straps
10389142000190 - Talymed 10 cm x 10 cm2020-09-08 Talymed 10 cm x 10 cm
10389142000046 - Talymed 3 cm x 3 cm 2020-09-08 Talymed 3 cm x 3 cm
10389142000114 - mrdh bandage 10 cm x 10 cm2020-04-17 mrdh Bandage 10 cm x 10 cm (4" x 4")
10389142000121 - mrdh Bandage 5 cm x 5 cm2020-04-17 mrdh bandage 5 cm x 5 cm (2 "x 2")
00389142000209 - Talymed dressing 5 cm x 5 cm2020-04-16 Talymed dressing 5 cm x 5 cm
00389142000018 - Syvek Radial Patch2020-02-13 Syvek Radial Patch
20389142000067 - Syvek Excel Patch2020-01-28 Syvek Excel Patch
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