XPRESS-WAY RX

GUDID 04540778133976

The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpre

KANEKA CORPORATION

Thrombectomy suction catheter

• Primary Device ID: 04540778133976
• NIH Device Record Key: 8c7d7d49-fcc6-4551-acbe-4b511310f65c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPRESS-WAY RX
• Version Model Number: T2R6SA4A
• Company DUNS: 690535406
• Company Name: KANEKA CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com
• Phone: 1-800-526-3521
• Email: takuji.hasegawa@kaneka.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in a cool, dark and dry place, avoiding exposure to water, direct sunlight, extreme temperature, or high humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778133976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101839

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [XPRESS-WAY RX]

• 04540778133983: The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from v
• 04540778133976: The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from v