FDA.reportPublic FDA data

SyvekExcel Vascular Access Hemostasis System

Primary DI
00389142000056
Brand
SyvekExcel Vascular Access Hemostasis System
Company
Marine Polymer Technologies, Inc.
Model
400-16-05
Catalog number
400-16-05
Device description
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.
Published
2016-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053300000SYVEKEXCELMarine Polymer Technologies, Inc.2006-03-28DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10389142000053PackageGS14Not in Commercial Distribution
00389142000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038914200005310389142000053
00389142000056003891420000563891420000560389142000056

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-888-666-2560pattid@webmpt.com

Regulatory Flags#

DUNS number
809739386
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00389142000032Syvek Brace with Straps420-052020-10-22
00389142000155Syvek Excel Vascular Access Hemostasis Kit400-16-052018-12-17
00389142000001Syvek Radial Band420-02420-022016-08-05
00389142000049Talymed 3 cm x 3 cm 400-352020-08-31
00389142000063Syvek Excel Patch400-162020-01-20
00389142000070Glyko SL Patch 3 cm x 3 cm400-132020-01-20
00389142000087Syvek Patch400-022020-01-20
00389142000094Syvek NT Patch400-092020-01-20
00389142000100Syvek SP Patch400-122020-01-20
00389142000117mrdh bandage 10 cm x 10 cm400-142020-04-09
00389142000124mrdh Bandage 5 cm x 5 cm400-252020-04-09
00389142000131Glyko SL Patch 4 cm x 2 cm400-262020-01-20
00389142000148Glyko SL Patch 4 cm x 4 cm400-242020-01-20
00389142000193Talymed 10 cm x 10 cm400-192020-08-31
00389142000209Talymed dressing 5 cm x 5 cm400-202020-04-08
00389142000018Syvek Radial Patch400-292020-02-05
10389142000039Syvek Brace with Straps420-052020-10-22
10389142000190Talymed 10 cm x 10 cm400-192020-08-31
10389142000046Talymed 3 cm x 3 cm 400-352020-08-31
10389142000114mrdh bandage 10 cm x 10 cm400-142020-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
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00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
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00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
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00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
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00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30