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 Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter 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