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

• Primary Device ID: 00389142000155
• NIH Device Record Key: e9e565e7-1d11-4df7-bc28-ac67d60e7423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syvek Excel Vascular Access Hemostasis Kit
• Version Model Number: 400-16-05
• Company DUNS: 809739386
• Company Name: MARINE POLYMER TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389142000056 [Previous]
GS1	00389142000155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053300

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-12-17

Devices Manufactured by MARINE POLYMER TECHNOLOGIES, INC.

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