ThruPort Systems Embol-X Introducer Sheath EXIS

GUDID 00690103192049

EMBOL-X INTRODUCER SHEATH

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00690103192049
• NIH Device Record Key: b975cff6-9f98-44d0-92f5-3d8b5960ff03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThruPort Systems Embol-X Introducer Sheath
• Version Model Number: EXIS
• Catalog Number: EXIS
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: false
• 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)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103192049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123714

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-08-31

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