DEVICE: XPRESS-WAY RX Catheter (6F LD-Version) (04540778139602)

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Device Identifier (DI) Information

XPRESS-WAY RX Catheter (6F LD-Version)
T2R6SA4L

KANEKA CORPORATION
04540778139602
GS1
1
The Xpress-Way RX Extraction Catheter is indicated for thrombi the removal of fresh, soft emboli and from vessels in the coronary and peripheral vasculature. The Xpress-Way RX Extraction Catheter is not intended for use in the cerebral vasculature.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Thrombectomy suction catheter A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DXE Catheter, Embolectomy
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Specify: Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Compatible Guide Catheter; 6 French
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Device Status

In Commercial Distribution
September 17, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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1-800-526-3521
takuji.hasegawa@kaneka.com
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