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

• Primary Device ID: 10389142000053
• NIH Device Record Key: 74c3931f-456e-4313-a997-21f1bde11b39
• Commercial Distribution Discontinuation: 2018-11-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SyvekExcel Vascular Access Hemostasis System
• Version Model Number: 400-16-05
• Catalog 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 [Primary]
GS1	10389142000053 [Package]; Contains: 00389142000056; Package: Case [4 Units]; Discontinued: 2018-11-06; Not in Commercial Distribution

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: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-08-05

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