SyvekExcel Vascular Access Hemostasis System 400-16-05

GUDID 10389142000053

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.

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 ID10389142000053
NIH Device Record Key74c3931f-456e-4313-a997-21f1bde11b39
Commercial Distribution Discontinuation2018-11-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSyvekExcel Vascular Access Hemostasis System
Version Model Number400-16-05
Catalog 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 [Primary]
GS110389142000053 [Package]
Contains: 00389142000056
Package: Case [4 Units]
Discontinued: 2018-11-06
Not in Commercial Distribution

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 Number6
Public Version Date2019-12-11
Device Publish Date2016-08-05

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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