DEVICE: SyvekExcel Vascular Access Hemostasis System (00389142000056)

Device Identifier (DI) Information

SyvekExcel Vascular Access Hemostasis System
400-16-05
Not in Commercial Distribution
400-16-05
MARINE POLYMER TECHNOLOGIES, INC.
00389142000056
GS1
November 06, 2018
1
809739386 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular catheterization support kit A collection of sterile devices intended to support a central venous and/or aterial catheterization procedure, and/or ongoing vascular catheter maintanence. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintanence (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.
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FDA Product Code

[?]
Product Code Product Code Name
DXC Clamp, Vascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K053300 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

74c3931f-456e-4313-a997-21f1bde11b39
December 18, 2018
5
August 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10389142000053 4 00389142000056 2018-11-06 Not in Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-888-666-2560
pattid@webmpt.com
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