FDA.reportPublic FDA data

Syvek Excel Vascular Access Hemostasis Kit

Primary DI
00389142000155
Brand
Syvek Excel Vascular Access Hemostasis Kit
Company
Marine Polymer Technologies, Inc.
Model
400-16-05
Device description
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.
Published
2018-12-17
Public version status
Update
Distribution status
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
00389142000056PreviousGS10
00389142000155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389142000056003891420000563891420000560389142000056
00389142000155003891420001553891420001550389142000155

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00389142000056SyvekExcel Vascular Access Hemostasis System400-16-05400-16-052016-08-05
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

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